Total ankle replacement trial and preparation systems, guides, instruments and related methods

ABSTRACT

Instruments, guides, systems and related methods for total ankle prostheses are disclosed. The instruments, guides, systems and related methods facilitate preparation of a tibia and/or talus of a patient for implantation of a total ankle prosthesis therein. The instruments, guides, systems and related methods also facilitate selection of a particular size of a tibial component, a talus component and/or a tibial insert of the total ankle prosthesis that suits the patient. The instruments, guides, systems and related methods include a tibial trial component, a talar trial component and tibial insert trial component that replicate one or more aspects of the tibial component, the talus component and the tibial insert, respectively, of the total ankle prosthesis. The talar trial component includes an articulation surface that articulates with the tibial insert trial component, and slots that facilitate chamfered resection of the patient&#39;s talus for the implantation of the talus component thereon.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Application No.PCT/US2019/066404, filed Dec. 13, 2019, and entitled Instruments, Guidesand Related Methods for Total Ankle Replacement, which claims prioritybenefit of U.S. Provisional Patent Application No. 62/779,092, filedDec. 13, 2018, and entitled Instruments, Guides and Related Methods forTotal Ankle Replacement, and U.S. Provisional Patent Application No.62/898,854, filed Sep. 11, 2019, and entitled “Distractors HavingAttachable Paddles, Impaction Devices, And Methods For Use In TotalAnkle Replacement,” which are hereby incorporated herein by reference intheir entireties.

TECHNICAL FIELD

The present disclosure relates generally to general, podiatric, andorthopaedic surgery related to joint deformities. More specifically, butnot exclusively, the present disclosure relates to instruments, guides,systems and related methods for maintaining, correcting and/or repairinga joint deformity and/or injury.

BACKGROUND

Total ankle replacement (TAR), or ankle arthroplasty, is a surgicalprocedure to replace deformed and/or damaged articular surfaces of thehuman ankle joint with a prosthetic joint. TAR is becoming the treatmentof choice for patients with a deformed and/or injured/damaged anklejoint, replacing the conventional use of arthrodesis (i.e. fusion of theankle bones). One of the main advantages of TAR compared with anklearthrodesis is preservation of functional range of motion (ROM), whichis sacrificed in ankle fusion. Improved ROM allows patients to betterperform activities of daily living and possibly regain athleticactivities

Many types of total ankle prostheses have been developed, such as thecylindric-type ankle replacement prosthesis, the spherical-type anklereplacement prosthesis, and the sliding cylindric-type ankle replacementprosthesis. These and other typical total ankle replacement (TAR)prosthesis comprise a tibial prosthesis component, a talus prosthesiscomponent, and a tibial bearing or insert component positioned betweenthe tibial and talus prosthesis components. In these types of TARprostheses, the tibial component is implanted on/in a tibia, the taluscomponent is implanted on/in a talus, and the tibial insert is fixed tothe tibial component and articulates with the talus component to form areplacement ankle joint.

The proper size and position/orientation/alignment of the tibialcomponent of a TAR prosthesis with respect to the distal end of a tibiaand the corresponding ankle joint, the proper size andposition/orientation of the talus component of the TAR prosthesis withrespect to the proximal end of a talus and the corresponding anklejoint, and the proper size and position/orientation/alignment of thetibial insert of the TAR prosthesis with respect to the tibialcomponent, the talus component and the corresponding ankle joint, areall important to achieving a stable replacement ankle joint and areplacement ankle joint that provides for full articulation/motion(e.g., achieving a range of motion of typical “healthy” ankle joints).For example, proper sizing and position/orientation of the tibialprosthesis, the talus prosthesis and the tibial insert of a TARprosthesis with respect to an ankle joint of a particular patient canprevent overstuffing or understuffing of the replacement ankle joint(and thereby provide full articulation/motion) and can ensure propercoverage of the tibial prosthesis on the tibial and the talus prosthesison the talus. As another example, the position/orientation/alignment ofthe tibial prosthesis, the talus prosthesis and the tibial insert withrespect to the mechanical axis of an ankle joint of a particular patient(e.g., the mechanical axis of the tibia) can ensure the mechanicalforces of the replacement ankle joint are properly distributed and fulland properly-oriented range of motion is achieved.

Total ankle replacement instrumentation, guides, systems and methodsthat facilitate the selection of a properly sized tibial prosthesis,talus prosthesis, and tibial insert of a total ankle replacement implantsystem for an ankle joint of a particular patient are thereby desirable.Further, total ankle replacement instrumentation, guides, systems andmethods that facilitate implantation of the tibial prosthesis in/on atibia, and implantation of the talus prosthesis in/on a talus, of atotal ankle replacement implant system in proper positions andorientations (and thereby the proper position and orientation of thecorresponding tibial insert) for an ankle joint of a particular patientare thereby also desirable.

SUMMARY

The present disclosure is directed toward instruments, guides, systemsand related methods for total ankle replacement prostheses. Theinstruments, guides, systems and related methods may facilitatepreparation of a tibia and/or talus of a patient for implantation of atotal ankle prosthesis therein. The instruments, guides, systems andrelated methods may also facilitate selection of a particular size of atibial component, a talus component and/or a tibial insert of the totalankle prosthesis that suits the patient. The instruments, guides,systems and related methods include a tibial trial component, atalar/talus trial component and tibial insert trial component thatreplicate one or more aspects of the tibial component, the taluscomponent and the tibial insert, respectively, of the total ankleprosthesis.

In one aspect of the present application, a total ankle replacement(TAR) trial and bone preparation guide system comprising a tibial trialand bone preparation first component and a talar trial and bonepreparation second component is disclosed. The tibial trial and bonepreparation first component comprises a base portion and an arm portion.The base portion comprises a first side with a first tibial engagementsurface configured to engage a resected distal tibia and at least onebone aperture formation guide through hole extending from the firsttibial engagement surface to a second tibial insert engagement side, andthe arm portion extends proximally from an anterior portion of the baseportion and is configured to engage an anterior side of the resecteddistal tibia. The talar trial and bone preparation second componentcomprises a first talar engagement surface, a posterior trialarticulation surface, an anterior window, a posterior cut slot and aplurality of pin apertures. The first talar engagement surface ispositioned on a distal side of the second component and is configured toengage a portion of a resected talus. The posterior trial articulationsurface is positioned on a proximal side of the second component and isanteriorly-posteriorly arcuately convex. The anterior window extendsthrough the second component between the proximal side and the distalside thereof. The posterior cut slot extends through the secondcomponent between the proximal side and the distal side thereof that isangled posteriorly as in extends from the proximal side to the distalside. The plurality of pin apertures extend through the second componentbetween the proximal side and the distal side.

In some embodiments, the resected distal tibia and the resected talusfor implantation therein and therebetween, a TAR prosthesis comprising atibial component comprising a second tibial engagement surface and atleast one bone engagement projection, a tibial insert configured toremovably couple with the tibial component and comprising a secondtibial articulation surface, and a talar component comprising a secondtalar engagement surface and a talar articulation surface thatarticulates with the second tibial articulation surface.

In some embodiments, the system further comprises a tibial trial insertcomprising a distal side with a first talar trial engagement surfacethat is configured to engage the posterior trial articulation surface ofthe second component, and a proximal side configured to removably couplewith the second tibial insert engagement side of the first component. Insome embodiments, the second tibial insert engagement side of the firstcomponent comprises a coupling slot, and wherein the tibial trial insertcomprises a coupling projection configured to removably mate within thecoupling slot. In some embodiments, the coupling slot is a dove-tailshaped slot, and wherein the coupling projection is a dove-tail shapedprojection configured to mate with the dove-tail shaped slot. In someembodiments, the coupling slot and the coupling projection extend andare elongated anteriorly-posteriorly. In some embodiments, at least onethrough hole of the at least one bone aperture formation guide throughhole is positioned within the coupling slot.

In some embodiments, the configuration of the first talar trialengagement surface corresponds to at least a portion of the secondtibial articulation surface. In some embodiments, the first talar trialengagement surface is arcuately concave anteriorly-posteriorly. In someembodiments, the first talar trial engagement surface comprises ananterior rail portion that extends medially-laterally and defines anengagement surface that is flat or convex anteriorly-posteriorly, and aposterior rail portion that extends medially-laterally and defines anengagement surface that is flat or convex anteriorly-posteriorly. Insome embodiments, the first talar trial engagement surface furthercomprises a strut portion that extends anteriorly-posteriorly, andwherein the posterior trial articulation surface of the second componentcomprises a strut slot that extends anteriorly-posteriorly and isconfigured to accept the strut portion therein.

In some embodiments, at least a portion of the first tibial engagementsurface corresponds in size and shape to at least a portion of thesecond tibial engagement surface.

In some embodiments, the first tibial engagement surface is convexmedially-laterally.

In some embodiments, the first side of the base portion of the firstcomponent includes at least one reference slot extendingmedially-laterally through at least a portion of the first tibialengagement surface. In some embodiments, the at least one reference slotcomprises at least one of: a center reference slot positioned in themedial-lateral center of the base portion and/or corresponding to themedial-lateral center of the tibial component; a bone aperture formationreference slot extending through at least a portion of the at least onebone aperture formation guide through hole; an anterior reference slotpositioned in an anterior end portion of the base portion correspondingto an anterior end of the tibial component; and an posterior referenceslot positioned in a posterior end portion of the base portioncorresponding to a posterior end of the tibial component.

In some embodiments, the arm portion of the first component comprises aplurality of pin through holes extending therethroughanteriorly-posteriorly. In some embodiments, the arm portion of thefirst component comprises a medial wing and a lateral wing, the medialand lateral wings each comprising at least one pin through hole of theplurality of pin through holes, and wherein the at least one pin throughhole of the medial and lateral wings converge medially-laterally as theyextend posteriorly. In some embodiments, the plurality of pin throughholes comprise at least one pair of aligned pin through holes that aremedially-laterally spaced.

In some embodiments, the arm portion of the first component comprises apositioning mechanism that is configured to engage the anterior side ofthe resected distal tibia and adjust the anterior-posterior position ofthe base portion of the first component relative to the resected distaltibia. In some embodiments, the positioning mechanism comprises at leastone adjustment screw threadably coupled with the arm portion.

In some embodiments, the first talar engagement surface is planar and isconfigured to engage a planar portion of the resected talus. In someembodiments, the first talar engagement surface comprises medial andlateral side edges that are exposed at medial and lateral sides of thesecond component. In some embodiments, the distal side of the secondcomponent further comprises a medially-laterally extending centerreference slot extending through the first talar engagement surfacecorresponding to the medial-lateral center of the talar component, themedially-laterally extending center reference slot being exposed atmedial and lateral sides of the second component.

In some embodiments, the posterior cut slot is exposed at medial andlateral sides of the second component at the distal side of the secondcomponent. In some embodiments, the posterior cut slot defines aposterior end of the medially-laterally extending center reference slot.

In some embodiments, the distal side of the second component furthercomprises a medially-laterally extending anterior reference slot, themedially-laterally extending anterior reference slot being exposed atmedial and lateral sides of the second component and corresponding tothe position and orientation of an anterior-posterior pathway of theposterior trial articulation surface at the distal side of the secondcomponent.

In some embodiments, the system further comprises at least one anteriorcut guide configured to engage the proximal side of the second componentand extend at least partially over the anterior window, the at least oneanterior cut guide comprising a bone cutting guide through holeconfigured to mate with at least one cutting implement to form ananterior chamfer on the resected talus. In some embodiments, the distalside of the second component further comprises a medially-laterallyextending anterior cut reference slot, the medially-laterally extendinganterior cut reference slot being exposed at medial and lateral sides ofthe second component and corresponding to the position and orientationof the anterior chamfer on the resected talus.

In some embodiments, the posterior trial articulation surfacecorresponds in size and shape to at least a portion of the talararticulation surface of the talar component. In some embodiments, theposterior cut slot is positioned anteriorly-posteriorly between at leasta portion of the posterior trial articulation surface and the anteriorwindow. In some embodiments, the posterior cut slot is configured toaccept a cutting blade therethrough to form a posterior chamfer on theresected talus.

In some embodiments, the second component further comprises a pluralityof pin through holes extending therethrough between the proximal anddistal sides thereof. In some embodiments, the plurality of pin throughholes of the second component comprise at least one pair of throughholes that are medially-laterally spaced and converge medially-laterallyas they extend from the proximal side to the and distal side of thesecond component. In some embodiments, the plurality of pin throughholes of the second component comprise at least one pair of aligned pinthrough holes that are medially-laterally spaced.

In some embodiments, the second component further comprises a handlethat forms an anterior end of the second component. In some embodiments,the second component further comprises a socket that forms an anteriorend of the second component. In some embodiments, the system furthercomprises a distractor, and wherein the socket is configured to couplewith a first arm of the distractor. In some embodiments, the distractorfurther comprises a second arm with a paddle coupled thereto, andwherein the paddle is configured to engage with the second tibial insertengagement side of the base portion of the first component.

In some embodiments, the system further comprises a chamfer checkerinstrument, the chamfer checker instrument comprising at least one thirdtalar engagement surface configured to engage the resected talus, afourth talar engagement surface extending from the at least one thirdtalar engagement surface configured to engage an anterior chamfer of theresected talus formed via the anterior window of the second component,and a fifth talar engagement surface extending from the at least onethird talar engagement surface configured to engage a posterior chamferof the resected talus formed via the cut slot of the second component.In some embodiments, the at least one third talar engagement surfacecomprises a medially-laterally extending center reference slotcorresponding to the medial-lateral center of the talar component, thecenter reference slot of the at least one third talar engagement surfacebeing exposed at medial and lateral sides of the chamfer checker. Insome embodiments, the chamfer checker further comprises first and secondmedially-laterally extending through hole positioned proximally of theat least one third talar engagement surface, the firstmedially-laterally extending through hole being tangent to a referenceline extending along the fourth talar engagement surface and the secondmedially-laterally extending through hole being tangent to a referenceline extending along the fifth talar engagement surface.

In some embodiments, the system further comprises a talar chamfer trialcomprising: a fifth talar engagement surface on a distal side of thetalar chamfer trial configured to engage the resected talus; a secondposterior trial articulation surface on a proximal side of the talarchamfer trial that comprises an anteriorly-posteriorly andmedially-laterally arcuately convex portion; at least one bone apertureformation guide through hole; and a plurality of pin through holesextending between the proximal and distal sides thereof. In someembodiments, at least a portion of the second posterior trialarticulation surface corresponds in size and shape to at least a portionof the second tibial engagement surface. In some embodiments, the fifthtalar engagement surface comprises a first planar surface for engaging aplanar surface of the resected talus, a second planar surface extendinganteriorly from the first planar surface on a distal angle configured toengage an anterior chamfer surface of the resected talus formed via theanterior window of the second component, and a third planar surfaceextending posteriorly from the first planar surface on a distal angleconfigured to engage a posterior chamfer of the resected talus formedvia the cut slot of the second component. In some embodiments, the atleast one bone aperture formation guide through hole of the talarchamfer trial comprises an elongated slot at an anterior end portion ofthe talar chamfer trial that extends through the second planar surface.In some embodiments, the system further comprises a bone apertureformation guide configured to couple to the anterior end portion of thetalar chamfer trial, the bone aperture formation guide comprising asecond elongated slot that extends over the elongated slot when coupledto the anterior end portion, the second elongated slot configured toaccept a bone cutting instrument therethrough to form an elongatedaperture in the anterior chamfer surface of the resected talus formedvia the anterior window of the second component. In some embodiments,the at least one bone aperture formation guide through hole comprises apair of medially-laterally spaced drill guide through holes that extendthrough the second posterior trial articulation surface to the distalside of the talar chamfer trial.

In another aspect of the present application, a method comprisingtrialing a total ankle replacement (TAR) prosthesis, preparing aresected tibia of the ankle joint, and preparing the resected talus ofthe ankle joint. The trialing the TAR prosthesis in the ankle jointcomprises trialing a TAR prosthesis that includes a tibial component, atibial insert with a tibial articulation surface, and a talar componentwith a talar articulation surface via a total ankle replacement (TAR)guide system. The TAR guide system comprises a tibial trial and bonepreparation first component and a talar trial and bone preparationsecond component is disclosed. The tibial trial and bone preparationfirst component comprises a base portion and an arm portion. The baseportion comprises a first side with a first tibial engagement surfaceconfigured to engage a resected distal tibia and at least one boneaperture formation guide through hole extending from the first tibialengagement surface to a second tibial insert engagement side, and thearm portion extends proximally from an anterior portion of the baseportion and is configured to engage an anterior side of the resecteddistal tibia. The talar trial and bone preparation second componentcomprises a first talar engagement surface, a posterior trialarticulation surface, an anterior window, a posterior cut slot and aplurality of pin apertures. The first talar engagement surface ispositioned on a distal side of the second component and is configured toengage a portion of a resected talus. The posterior trial articulationsurface is positioned on a proximal side of the second component and isanteriorly-posteriorly arcuately convex. The anterior window extendsthrough the second component between the proximal side and the distalside thereof. The posterior cut slot extends through the secondcomponent between the proximal side and the distal side thereof that isangled posteriorly as in extends from the proximal side to the distalside. The plurality of pin apertures extend through the second componentbetween the proximal side and the distal side. The preparing theresected tibia of the ankle joint comprises preparing the resected tibiaof the ankle joint for the implantation of at least one projection of anengagement side of the tibial component therein, comprising coupling thearm portion of the first component to the anterior side of the resecteddistal tibia with the first tibial engagement surface of the firstcomponent engaged with the resected distal tibia, and passing at leastone projection of a bone aperture formation instrument though the atleast one bone aperture formation guide through hole of the base portionof the first component and into the resected distal tibia to form atleast one aperture in the resected distal tibia that is configured toaccept the at least one projection of the tibial component therein. Thepreparing the resected talus of the ankle joint comprises preparing theresected talus of the ankle joint for coupling with an engagement sideof the talar component, comprising: coupling the second component to theresected distal talus such that the first talar engagement surface ofthe second component engage a surface portion of the resected talus;passing a bone cutting instrument through the anterior window of thesecond component to form an anterior chamfer surface on the resectedtalus; and passing a bone cutting blade through the posterior cut slotthe second component to form a posterior chamfer surface on the resectedtalus.

In some embodiments, the system further comprises a talar chamfer trialcomprising: a second talar engagement surface on a distal side of thetalar chamfer trial configured to engage the surface portion, theanterior chamfer and the posterior chamfer of the resected talus; asecond posterior trial articulation surface on a proximal side of thetalar chamfer trial that comprises an anteriorly-posteriorly andmedially-laterally arcuately convex portion; at least one bone apertureformation guide through hole; and a plurality of pin through holesextending between the proximal and distal sides thereof. In someembodiments, the method further comprises preparing the resected talusof the ankle joint for the implantation of at least one projection ofthe engagement side of the talar component therein, comprising: couplingthe second talar engagement surface in engagement with the surfaceportion, the anterior chamfer and the posterior chamfer of the resectedtalus by passing a plurality of pin through the plurality of pin throughholes and into the resected talus; and passing at least one projectionof a bone aperture formation instrument though the at least one boneaperture formation guide through hole of the talar chamfer trial andinto the resected talus to form at least one aperture in the resectedtalus that is configured to accept the at least one projection of thetalar component therein.

In another aspect of the present application, a total ankle replacement(TAR) guide system for a TAR prosthesis including a tibial component, atibial insert with a tibial articulation surface, and a talar componentwith a talar articulation surface and a talar engagement side opposingthe articulation surface is disclosed. The TAR guide system comprises atibial trial component, a tibial trial insert, and a talar trialcomponent. The tibial trial component comprises a base portion and anarm portion extending proximally from an anterior portion of the baseportion. The tibial trial insert comprises an anterior rail portion thatextends in a medial-lateral direction and defines an engagement surfacethat is flat or convex in the anterior-posterior direction, a posteriorrail portion that extends in a medial-lateral direction and defines anengagement surface that is flat or convex in the anterior-posteriordirection, and a strut portion that extends in an anterior-posteriordirection. The anterior and posterior rail portions approximate anteriorand posterior portions of the tibial articulation surface of the tibialinsert. The talar trial component comprises a trial articulation surfacethat approximates the talar articulation surface of the talar component,a posterior cut slot extending through the articulation surface in themedial-lateral direction, a strut slot extending through thearticulation surface in the anterior-posterior direction, an anteriorwindow positioned anterior to the posterior cut slot. The tibial trialinsert and the tibial trial are coupled together. The anterior andposterior rail portions are engaged with the trial articulation surface,and the strut portion is positioned within the strut slot. In someembodiments, the talar trial component further comprises a pair ofapertures extending therethrough that converge or diverge.

In another aspect of the present application a method is disclosed. Themethod comprises trialing a total ankle replacement (TAR) prosthesis inan ankle joint that includes a tibial component, a tibial insert with atibial articulation surface, and a talar component with a talararticulation surface via a total ankle replacement (TAR) guide system.The TAR guide system comprises a tibial trial component, a tibial trialinsert, and a talar trial component. The tibial trial componentcomprises a base portion and an arm portion extending proximally from ananterior portion of the base portion. The tibial trial insert comprisesan anterior rail portion that extends in a medial-lateral direction anddefines an engagement surface that is flat or convex in theanterior-posterior direction, a posterior rail portion that extends in amedial-lateral direction and defines an engagement surface that is flator convex in the anterior-posterior direction, and a strut portion thatextends in an anterior-posterior direction. The anterior and posteriorrail portions approximate anterior and posterior portions of the tibialarticulation surface of the tibial insert. The talar trial componentcomprises a trial articulation surface that approximates the talararticulation surface of the talar component, a posterior cut slotextending through the articulation surface in the medial-lateraldirection, a strut slot extending through the articulation surface inthe anterior-posterior direction, an anterior window positioned anteriorto the posterior cut slot. The tibial trial insert and the tibial trialare coupled together. The anterior and posterior rail portions areengaged with the trial articulation surface, and the strut portion ispositioned within the strut slot. The method further comprises preparinga talus bone of the ankle joint for the implantation of the talarcomponent therein by resecting a posterior portion of the talus bone viaa cut slot of the talar trial component, and by resecting an anteriorportion of the talus bone via an anterior window of the talar trialcomponent.

In some embodiments, the talar trial component further comprises a pairof apertures extending therethrough that converge or diverge.

These and other objects, features and advantages of this disclosure willbecome apparent from the following detailed description of the variousaspects of the disclosure taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the disclosure andtogether with the detailed description herein, serve to explain theprinciples of the disclosure. It is emphasized that, in accordance withthe standard practice in the industry, various features are not drawn toscale. In fact, the dimensions of the various features may bearbitrarily increased or reduced for clarity of discussion. The drawingsare only for purposes of illustrating preferred embodiments and are notto be construed as limiting the disclosure.

FIG. 1A illustrates a side view of an exemplary embodiment of a totalankle replacement (TAR) prosthesis formed of tibial component implantedon the tibia, a talar component implanted on the talus, and a tibialinsert coupled to the tibial component and articulating on the talarcomponent, in accordance with an aspect of the present disclosure;

FIG. 1B illustrates a perspective view of the exemplary TAR prosthesisof FIG. 1A, in accordance with an aspect of the present disclosure;

FIG. 2 illustrates an elevational perspective view of a total anklereplacement (TAR) trial and guide system including a tibial trial guide,a tibial trial insert and a talar trial guide for facilitating selectionof a TAR prosthesis and preparation of a tibia and talus therefore, inaccordance with an aspect of the present disclosure;

FIG. 3 illustrates a bottom perspective view of the TAR trial and guidesystem of FIG. 2, in accordance with an aspect of the presentdisclosure;

FIG. 4 illustrates a medial/lateral side view of the TAR trial and guidesystem of FIG. 2, in accordance with an aspect of the presentdisclosure;

FIG. 5 illustrates an anterior view of the TAR trial and guide system ofFIG. 2, in accordance with an aspect of the present disclosure;

FIG. 6 illustrates a posterior view of the TAR trial and guide system ofFIG. 2, in accordance with an aspect of the present disclosure;

FIG. 7 illustrates a proximal view of the TAR trial and guide system ofFIG. 2, in accordance with an aspect of the present disclosure;

FIG. 8 illustrates a distal view of the TAR trial and guide system ofFIG. 2, in accordance with an aspect of the present disclosure;

FIG. 9 illustrates an elevational perspective view of the tibial trialguide of the TAR trial and guide system of FIG. 2, in accordance with anaspect of the present disclosure;

FIG. 10 illustrates another elevational perspective view of the tibialtrial guide of FIG. 9, in accordance with an aspect of the presentdisclosure;

FIG. 11 illustrates a bottom perspective view of the tibial trial guideof FIG. 9, in accordance with an aspect of the present disclosure;

FIG. 12 illustrates a bottom perspective view of the tibial trial guideof FIG. 9, in accordance with an aspect of the present disclosure;

FIG. 13 illustrates a bottom view of the tibial trial guide of FIG. 9,in accordance with an aspect of the present disclosure;

FIG. 14 illustrates a medial side view of the tibial trial guide of FIG.9, in accordance with an aspect of the present disclosure;

FIG. 15 illustrates a lateral side view of the tibial trial guide ofFIG. 9, in accordance with an aspect of the present disclosure;

FIG. 16 illustrates a posterior perspective view of the tibial trialguide of FIG. 9, in accordance with an aspect of the present disclosure;

FIG. 17 illustrates an anterior view of the tibial trial guide of FIG.9, in accordance with an aspect of the present disclosure;

FIG. 18 illustrates a posterior view of the tibial trial guide of FIG.9, in accordance with an aspect of the present disclosure;

FIG. 19 illustrates an elevational anterior perspective view of thetibial trial insert of the TAR trial and guide system of FIG. 2, inaccordance with an aspect of the present disclosure;

FIG. 20 illustrates an elevational posterior perspective view of thetibial trial insert of FIG. 19, in accordance with an aspect of thepresent disclosure;

FIG. 21 illustrates a bottom anterior perspective view of the tibialtrial insert of FIG. 19, in accordance with an aspect of the presentdisclosure;

FIG. 22 illustrates a bottom posterior perspective view of the tibialtrial insert of FIG. 19, in accordance with an aspect of the presentdisclosure;

FIG. 23 illustrates a proximal view of the tibial trial insert of FIG.19, in accordance with an aspect of the present disclosure;

FIG. 24 illustrates a distal view of the tibial trial insert of FIG. 19,in accordance with an aspect of the present disclosure;

FIG. 25 illustrates a medial side view of the tibial trial insert ofFIG. 19, in accordance with an aspect of the present disclosure;

FIG. 26 illustrates a lateral side view of the tibial trial insert ofFIG. 19, in accordance with an aspect of the present disclosure;

FIG. 27 illustrates an anterior view of the tibial trial insert of FIG.19, in accordance with an aspect of the present disclosure;

FIG. 28 illustrates a posterior side view of the tibial trial insert ofFIG. 19, in accordance with an aspect of the present disclosure;

FIG. 29 illustrates an elevational anterior perspective view of thetalar trial guide of the TAR trial and guide system of FIG. 2, inaccordance with an aspect of the present disclosure;

FIG. 30 illustrates an elevational posterior perspective view of thetalar trial guide of FIG. 29, in accordance with an aspect of thepresent disclosure;

FIG. 31 illustrates a lateral side view of the talar trial guide of FIG.29, in accordance with an aspect of the present disclosure;

FIG. 32 illustrates an anterior view of the talar trial guide of FIG.29, in accordance with an aspect of the present disclosure;

FIG. 33 illustrates a medial side view of the talar trial guide of FIG.29, in accordance with an aspect of the present disclosure;

FIG. 34 illustrates a posterior view of the talar trial guide of FIG.29, in accordance with an aspect of the present disclosure;

FIG. 35 illustrates a distal view of the talar trial guide of FIG. 29,in accordance with an aspect of the present disclosure;

FIG. 36 illustrates a proximal view of the talar trial guide of FIG. 29,in accordance with an aspect of the present disclosure;

FIG. 37 illustrates a posterior elevational perspective view of thetalus component of the TAR prosthesis of FIGS. 1A and 2B, in accordancewith an aspect of the present disclosure;

FIG. 38 illustrates an anterior bottom perspective view of the taluscomponent of FIG. 37, in accordance with an aspect of the presentdisclosure;

FIG. 39 illustrates a lateral side view of the talus component of FIG.37, in accordance with an aspect of the present disclosure;

FIG. 40 illustrates a proximal view of the talus component of FIG. 37,in accordance with an aspect of the present disclosure;

FIG. 41 illustrates a distal view of the talus component of FIG. 37, inaccordance with an aspect of the present disclosure;

FIG. 42 illustrates a posterior elevational perspective view of thetalus component of FIG. 37 overlaid with the talar trial guide of FIG.29, in accordance with an aspect of the present disclosure;

FIG. 43 illustrates a lateral side view of the talus component of FIG.37 overlaid with the talar trial guide of FIG. 29, in accordance with anaspect of the present disclosure;

FIG. 44 illustrates an elevational posterior perspective view of the TARprosthesis of FIGS. 1A and 2B forming an ankle joint between a tibia andtalus, in accordance with an aspect of the present disclosure;

FIG. 45 illustrates a lateral side view of the TAR prosthesis of FIGS.1A and 2B forming an ankle joint between a tibia and talus, inaccordance with an aspect of the present disclosure;

FIG. 46 illustrates an anterior view of the tibial trial guide of FIG. 9positioned on a resected distal tibia, in accordance with an aspect ofthe present disclosure;

FIG. 47 illustrates an anterior elevational perspective view of thetalar trial guide of FIG. 29 positioned on a talus, in accordance withan aspect of the present disclosure;

FIG. 48 illustrates an anterior elevational perspective view of thetalar trial guide of FIG. 29 and the tibial trial insert of FIG. 19positioned on a talus, in accordance with an aspect of the presentdisclosure;

FIG. 49 illustrates a medial perspective exploded view of the talartrial guide of FIG. 29, the tibial trial insert of FIG. 19 and the taluscomponent of FIG. 37, in accordance with an aspect of the presentdisclosure;

FIG. 50 illustrates a medial perspective view of the talar trial guideof FIG. 29 engaged with the tibial trial insert of FIG. 19, and thetalus component of FIG. 37 overlaid on the tibial trial insert of FIG.19, in accordance with an aspect of the present disclosure;

FIG. 51 illustrates a posterior elevational perspective view of thetalar trial guide of FIG. 29 engaged with the tibial trial insert ofFIG. 19, in accordance with an aspect of the present disclosure;

FIG. 52 illustrates an anterior elevational perspective view of thetalar trial guide of FIG. 29 engaged with the tibial trial insert ofFIG. 19, in accordance with an aspect of the present disclosure;

FIG. 53 illustrates a medial side view of the talar trial guide of FIG.29 engaged with the tibial trial insert of FIG. 19, in accordance withan aspect of the present disclosure;

FIG. 54 illustrates a distal view of the tibial trial insert of FIG. 19,in accordance with an aspect of the present disclosure;

FIG. 55 illustrates a series of cross-sectional views of the talar trialguide of FIG. 29 engaged with the tibial trial insert of FIG. 19 along arange of motion therebetween, in accordance with an aspect of thepresent disclosure;

FIG. 56 illustrates a series of additional cross-sectional views of thetalar trial guide of FIG. 29 engaged with the tibial trial insert ofFIG. 19 along a range of motion therebetween, in accordance with anaspect of the present disclosure;

FIG. 57 illustrates an anterior elevation perspective view of the tibialtrial guide of FIG. 9 engaged with a plurality of pin members and thetibial trial insert of FIG. 19, in accordance with an aspect of thepresent disclosure;

FIG. 58 illustrates a medial side view of the tibial trial guide of FIG.9 engaged with a plurality of pin members and the tibial trial insert ofFIG. 19, in accordance with an aspect of the present disclosure;

FIG. 59 illustrates an anterior view of the tibial trial guide of FIG. 9engaged with a plurality of pin members and the tibial trial insert ofFIG. 19, in accordance with an aspect of the present disclosure;

FIG. 60 illustrates an anterior elevation perspective view of the tibialtrial guide of FIG. 9 engaged with the tibial trial insert of FIG. 19,and the talar trial guide of FIG. 29 engaged with a plurality of pinmembers and the tibial trial insert of FIG. 19, in accordance with anaspect of the present disclosure;

FIG. 61 illustrates an anterior elevation view of the talar trial guideof FIG. 29 engaged with a plurality of pin members, in accordance withan aspect of the present disclosure;

FIG. 62 illustrates a medial elevation perspective view of the talartrial guide of FIG. 29 engaged with a plurality of pin members and abone removal guide, in accordance with an aspect of the presentdisclosure;

FIG. 63 illustrates a proximal view of the talar trial guide of FIG. 29engaged with the plurality of pin members and the bone removal guide ofFIG. 62, in accordance with an aspect of the present disclosure;

FIG. 64 illustrates a medial view of the talar trial guide of FIG. 29engaged with the plurality of pin members and the bone removal guide ofFIG. 62, in accordance with an aspect of the present disclosure;

FIG. 65 illustrates a posterior view of the talar trial guide of FIG. 29engaged with the plurality of pin members and the bone removal guide ofFIG. 62, in accordance with an aspect of the present disclosure;

FIG. 66 illustrates a medial view of the talar trial guide of FIG. 29engaged with the plurality of pin members and the bone removal guide ofFIG. 62, and a bone aperture formation instrument engaged with the boneremoval guide of FIG. 62, in accordance with an aspect of the presentdisclosure;

FIG. 67 illustrates a medial view of the talar trial guide of FIG. 29engaged with a bone cutting blade, a plurality of pin members and a bonecutting blade support member, and the tibial trial insert of FIG. 19overlaid on the talar trial guide of FIG. 29, in accordance with anaspect of the present disclosure;

FIG. 68 illustrates a medial elevational perspective view of the talartrial guide of FIG. 29 engaged with a bone cutting blade, a plurality ofpin members and a bone cutting blade support member, and the tibialtrial insert of FIG. 19 overlaid on the talar trial guide of FIG. 29, inaccordance with an aspect of the present disclosure;

FIG. 69 illustrates an anterior view of the talar trial guide of FIG. 29engaged with a bone cutting blade, a plurality of pin members and a bonecutting blade support member, and the tibial trial insert of FIG. 19overlaid on the talar trial guide of FIG. 29, in accordance with anaspect of the present disclosure;

FIG. 70 illustrates a medial elevation perspective view of the talartrial guide of FIG. 29 positioned on a resected talus, in accordancewith an aspect of the present disclosure;

FIG. 71 illustrates a medial side view of the talar trial guide and theresected talus of FIG. 71, in accordance with an aspect of the presentdisclosure;

FIG. 72 illustrates a medial elevation perspective view of the talartrial guide of FIG. 29 positioned on a resected and chamfered talus, inaccordance with an aspect of the present disclosure;

FIG. 73 illustrates a medial side view of the talar trial guide and theresected and chamfered talus of FIG. 72, in accordance with an aspect ofthe present disclosure;

FIG. 74 illustrates a medial side view of another TAR trial and guidesystem including a tibial trial guide, a first talar trial guide and adistractor for facilitating selection of a TAR prosthesis andpreparation of a tibia and talus therefore, in accordance with an aspectof the present disclosure;

FIG. 75 illustrates an anterior view of the TAR trial and guide systemof FIG. 74, in accordance with an aspect of the present disclosure;

FIG. 76 illustrates an elevational anterior perspective view of thetibial trial guide and the distractor of the TAR trial and guide systemof FIG. 74, in accordance with an aspect of the present disclosure;

FIG. 77 illustrates a distal medial perspective view of the tibial trialguide and the distractor of FIG. 76, in accordance with an aspect of thepresent disclosure;

FIG. 78 illustrates an elevational posterior perspective view of thetibial trial guide of the TAR trial and guide system of FIG. 74, inaccordance with an aspect of the present disclosure;

FIG. 79 illustrates a distal posterior perspective view of the tibialtrial guide of FIG. 78, in accordance with an aspect of the presentdisclosure;

FIG. 80 illustrates a proximal view of the tibial trial guide of FIG.78, in accordance with an aspect of the present disclosure;

FIG. 81 illustrates a distal perspective view of the tibial trial guideof FIG. 78, in accordance with an aspect of the present disclosure;

FIG. 82 illustrates a medial view of the tibial trial guide of FIG. 78,in accordance with an aspect of the present disclosure;

FIG. 83 illustrates an anterior view of the tibial trial guide of FIG.78, in accordance with an aspect of the present disclosure;

FIG. 84 illustrates a posterior view of the tibial trial guide of FIG.78, in accordance with an aspect of the present disclosure;

FIG. 85 illustrates a distal elevational perspective view of the firsttalar trial guide and the distractor of FIG. 76, in accordance with anaspect of the present disclosure;

FIG. 86 illustrates a distal medial perspective view of the tibial trialguide and the distractor of FIG. 85, in accordance with an aspect of thepresent disclosure;

FIG. 87 illustrates an elevational posterior perspective view of thefirst talar trial guide of the TAR trial and guide system of FIG. 74, inaccordance with an aspect of the present disclosure;

FIG. 88 illustrates a distal posterior perspective view of the firsttalar trial guide of FIG. 87, in accordance with an aspect of thepresent disclosure;

FIG. 89 illustrates a proximal view of the first talar trial guide ofFIG. 87, in accordance with an aspect of the present disclosure;

FIG. 90 illustrates a distal view of the first talar trial guide of FIG.87, in accordance with an aspect of the present disclosure;

FIG. 91 illustrates a medial side view of the first talar trial guide ofFIG. 87, in accordance with an aspect of the present disclosure;

FIG. 92 illustrates an anterior view of the first talar trial guide ofFIG. 87, in accordance with an aspect of the present disclosure;

FIG. 93 illustrates posterior view of the first talar trial guide ofFIG. 87, in accordance with an aspect of the present disclosure;

FIG. 94 illustrates a medial side view of the first talar trial guideand the distractor of FIG. 76 on a resected talus, and a bone cuttingblade cutting a posterior chamfer on the resected talus via the firsttalar trial guide, in accordance with an aspect of the presentdisclosure;

FIG. 95 illustrates an elevational anterior perspective view of thefirst talar trial guide of the TAR trial and guide system of FIG. 74 anda bone cutting blade cutting positioned within a cut slot thereof;

FIG. 96 illustrates an elevational anterior view of the first talartrial guide of the TAR trial and guide system of FIG. 74 on a resectedtalus, and a bone removal guide and bone cutting instrument cutting ananterior chamfer on the resected talus via the first talar trial guide,in accordance with an aspect of the present disclosure;

FIG. 97 illustrates an elevational anterior perspective view of thefirst talar trial guide of the TAR trial and guide system of FIG. 74 anda bone removal guide and bone cutting instrument engaged therewith, inaccordance with an aspect of the present disclosure;

FIG. 98 illustrates a medial side view of the first talar trial guide,the bone removal guide and the bone cutting instrument of FIG. 97, inaccordance with an aspect of the present disclosure;

FIG. 99 illustrates an elevational anterior view of the first talartrial guide of the TAR trial and guide system of FIG. 74 on a resectedtalus, and another bone removal guide and bone cutting instrumentfurther cutting an anterior chamfer on the resected talus via the firsttalar trial guide, in accordance with an aspect of the presentdisclosure;

FIG. 100 illustrates the tibial trial guide of the TAR trial and guidesystem of FIG. 74 engaged with a resected distal tibia and a chamferchecker instrument of the TAR trial and guide system engaged with aresected and chamfered talus, in accordance with an aspect of thepresent disclosure;

FIG. 101 illustrates an elevational anterior perspective view of thechamfer checker instrument of FIG. 100, in accordance with an aspect ofthe present disclosure;

FIG. 102 illustrates an distal posterior perspective view of the chamferchecker instrument of FIG. 100, in accordance with an aspect of thepresent disclosure;

FIG. 103 illustrates a medial side view of the chamfer checkerinstrument of FIG. 100, in accordance with an aspect of the presentdisclosure;

FIG. 104 illustrates an elevational anterior perspective view of anotherchamfer checker instrument for a TAR trial and guide system, inaccordance with an aspect of the present disclosure;

FIG. 105 illustrates a distal posterior perspective view of the chamferchecker instrument of FIG. 104, in accordance with an aspect of thepresent disclosure;

FIG. 106 illustrates a medial side view of the chamfer checkerinstrument of FIG. 104, in accordance with an aspect of the presentdisclosure;

FIG. 107 illustrates a distal medial side perspective view of the tibialtrial guide of FIG. 78 engaged with a tibial trial insert and a secondtalar trial guide of the TAR trial and guide system, in accordance withan aspect of the present disclosure;

FIG. 108 illustrates a medial side view of the tibial trial guide, thetibial trial insert and the second talar trial guide of FIG. 107, inaccordance with an aspect of the present disclosure;

FIG. 109 illustrates an anterior view of the tibial trial guide, thetibial trial insert and the second talar trial guide of FIG. 107, inaccordance with an aspect of the present disclosure;

FIG. 110 illustrates a medial side view of the tibial trial insert andthe second talar trial guide of FIG. 107, in accordance with an aspectof the present disclosure;

FIG. 111 illustrates an anterior view of the tibial trial insert and thesecond talar trial guide of FIG. 107, in accordance with an aspect ofthe present disclosure;

FIG. 112 illustrates an elevational anterior perspective view of thesecond talar trial guide of FIG. 107, in accordance with an aspect ofthe present disclosure;

FIG. 113 illustrates a distal posterior perspective view of the secondtalar trial guide of FIG. 112, in accordance with an aspect of thepresent disclosure;

FIG. 114 illustrates a lateral side view of the second talar trial guideof FIG. 112, in accordance with an aspect of the present disclosure;

FIG. 115 illustrates an elevational anterior view of the second talartrial guide of FIG. 112, in accordance with an aspect of the presentdisclosure;

FIG. 116 illustrates an elevational anterior perspective view of thetibial trial insert of FIG. 107, in accordance with an aspect of thepresent disclosure;

FIG. 117 illustrates a distal anterior perspective view of the tibialtrial insert of FIG. 116, in accordance with an aspect of the presentdisclosure;

FIG. 118 illustrates a distal view of the tibial trial insert of FIG.116, in accordance with an aspect of the present disclosure;

FIG. 119 illustrates a medial side view of the tibial trial insert ofFIG. 116, in accordance with an aspect of the present disclosure;

FIG. 120 illustrates an anterior view of the second talar trial guide ofFIG. 112 coupled to a resected and chamfered talus, in accordance withan aspect of the present disclosure;

FIG. 121 illustrates an elevational anterior perspective view of thesecond talar trial guide of FIG. 112 and a bone removal guide and bonecutting instrument engaged therewith, in accordance with an aspect ofthe present disclosure;

FIG. 122 illustrates an elevational posterior perspective view of thesecond talar trial guide, the bone removal guide and the bone cuttinginstrument of FIG. 121, in accordance with an aspect of the presentdisclosure;

FIG. 123 illustrates an anterior perspective view of the second talartrial guide, the bone removal guide and the bone cutting instrument ofFIG. 121, in accordance with an aspect of the present disclosure;

FIG. 124 illustrates a proximal view of the second talar trial guide,the bone removal guide and the bone cutting instrument of FIG. 121forming an aperture in a resected talus, in accordance with an aspect ofthe present disclosure;

FIG. 125 illustrates a anterior view of the second talar trial guide,the bone removal guide and the bone cutting instrument of FIG. 121forming an aperture in a resected talus, in accordance with an aspect ofthe present disclosure

FIG. 126 illustrates an elevational anterior perspective view of a thirdtalar trial guide and a bone aperture formation instrument engagedtherewith for a TAR trial and guide system, in accordance with an aspectof the present disclosure;

FIG. 127 illustrates an elevational posterior perspective view of thethird talar trial guide and the bone aperture formation instrument ofFIG. 126, in accordance with an aspect of the present disclosure;

FIG. 128 illustrates a medial side view of the third talar trial guideand the bone aperture formation instrument of FIG. 126, in accordancewith an aspect of the present disclosure;

FIG. 129 illustrates an elevational anterior perspective view of thethird talar trial guide of FIG. 126, in accordance with an aspect of thepresent disclosure;

FIG. 130 illustrates a distal anterior perspective view of the thirdtalar trial guide of FIG. 129, in accordance with an aspect of thepresent disclosure;

FIG. 131 illustrates a proximal view of the third talar trial guide ofFIG. 129, in accordance with an aspect of the present disclosure;

FIG. 132 illustrates a distal view of the third talar trial guide ofFIG. 129, in accordance with an aspect of the present disclosure; and

FIG. 133 illustrates a medial side view of the third talar trial guideof FIG. 129, in accordance with an aspect of the present disclosure.

DETAILED DESCRIPTION

Generally stated, disclosed herein are instruments, guides, systems andrelated methods for total ankle replacement prostheses. The instruments,guides, systems and related methods may facilitate preparation of atibia and/or talus of a patient for implantation of a total anklereplacement prosthesis therein. The instruments, guides, systems andrelated methods may also facilitate selection of a particular size of atibial component, a talus component and/or a tibial insert of the totalreplacement ankle prosthesis that suits the patient. The instruments,guides, systems and related methods include a tibial trial component, atalar/talus trial component and tibial insert trial component thatreplicate one or more aspects of the tibial component, the taluscomponent and the tibial insert, respectively, of the total ankleprosthesis. The talar trial component may include an articulationsurface that articulates with convex articulation surface of the tibialinsert trial component. The talar trial component may also include slotsthat facilitate resection of the patient's talus for the implantation ofthe talus component therein.

In this detailed description and the following claims, the wordsproximal, distal, anterior or plantar, posterior or dorsal, medial,lateral, superior and inferior are defined by their standard usage forindicating a particular part or portion of a bone, joint (or any otheranatomical structure) or implant according to the relative dispositionof the natural bone, joint (or any other anatomical structure) ordirectional terms of reference. For example, “proximal” means theportion of a device or instrument nearest the torso, while “distal”indicates the portion of the device or instrument farthest from thetorso. As for directional terms, “anterior” is a direction towards thefront side of the body, “posterior” means a direction towards the backside of the body, “medial” means towards the midline of the body,“lateral” is a direction towards the sides or away from the midline ofthe body, “superior” means a direction above and “inferior” means adirection below another object or structure. Further, specifically inregards to the foot and/or ankle, the term “dorsal” refers to the top ofthe foot and the term “plantar” refers the bottom of the foot.

Similarly, positions or directions may be used herein with reference toanatomical structures or surfaces. For example, as the currentinstruments, guides, systems and related methods (and componentsthereof) are described herein with reference to use with the bones ofthe ankle, the bones of the foot, ankle and lower leg may be used todescribe the surfaces, positions, directions or orientations of theinstruments, guides, systems and related methods (and componentsthereof). Further, the instruments, guides, systems and related methods,and the aspects, components, features and the like thereof, disclosedherein may be described with respect to one side of the body (e.g., theleft for right ankle) for brevity purposes. However, as the human bodyis relatively symmetrical or mirrored about a line of symmetry(midline), it is hereby expressly contemplated that the instruments,guides, systems and related methods, and the aspects, components,features and the like thereof, described and/or illustrated herein maybe changed, varied, modified, reconfigured or otherwise altered for useor association with another side of the body for a same or similarpurpose without departing from the spirit and scope of the disclosure.For example, the instruments, guides, systems and related methods, andthe aspects, components, features and the like thereof, described hereinwith respect to the right ankle of a patient may be mirrored so thatthey likewise function with the left ankle of the patient. Further, theinstruments, guides, systems and related methods, and the aspects,components, features and the like thereof, disclosed herein aredescribed with respect to the ankle for brevity purposes, but it shouldbe understood that the instruments, guides, systems and related methods(and components thereof) may be used with other joints of a human body(or other mammalian body) having similar structures.

Referring to the drawings, wherein like reference numerals are used toindicate like or analogous components throughout the several views, andwith particular reference to FIG. 1, there is illustrated an example ofa total ankle replacement (TAR) prosthesis 10. The TAR prosthesis 10includes a tibial prosthesis component or implant 12, a talar (or talus)prosthesis component or implant 14, and a tibial bearing or insertcomponent 16 positioned between the tibial and talar components 12, 14.The tibial component 12 of the TAR prosthesis 10 engages the distal endof a tibia 2 of a patient and may be implanted partially therein, asshown in FIG. 1. In some examples, the distal end of the tibia 2 may beresected, and the tibial component 12 may engage at least the resectedportion of the distal end of the tibia 2 and/or at least one post orother projection of the tibial component 12 may be implanted into theresected portion of the tibia 2. The talar/talus component 14 of the TARprosthesis 10 engages the proximal portion of a talus 4 of the patientand may be implanted partially therein, as shown in FIG. 1. In someexamples, the proximal portion or end of the talus 4 may be resected,and the talar component 14 may engage at least the resected portion ofthe proximal portion of the talus 4 and/or at least one post or otherprojection of the talar component 14 may be implanted into the resectedportion of the talus 4.

As shown in FIG. 1, the tibial insert 16 of the TAR prosthesis 10couples to the tibial component 12 and engages the talar component 14.The tibial insert 16 may fixedly or removably couple with the tibialcomponent 12 such that the tibial insert 16 is positioned at leastpartially between the tibial component 12 and the talar component 14.Specifically, as discussed further below, the tibial insert 16 and thetalar component 14 each include at least one articular surface thatengage and articulate with each other. The articular surface of thetibial insert 16 may be concave and is defined by at least one firstradius, and the articular surface of the talar component 14 may beconvex and is defined by at least one second radius. The articularsurfaces of the tibial insert 16 and the talar component 14 maycorrespond or match (e.g., the at least one first and second radiithereof may be the same or substantially similar). The tibial insert 16and the talar component 14 may articulate with each other viasliding/gliding motion over the articular surfaces thereof.

Turning to FIGS. 2-36, a total ankle replacement (TAR) guide,instrumentation and/or system 100 (and related methods) that facilitatesuse of a TAR prosthesis, such as TAR prosthesis 10 of FIG. 1, to replacean ankle joint of a patient is shown. The TAR guide 100 can facilitatethe selection of a properly sized tibial component 12, talar component14 and/or tibial insert 16 of the TAR prosthesis 10 based on thesize/configuration of the ankle joint of the particular patient. Forexample, as described further below, the TAR guide 100 may be positionedbetween the tibia and talus (potentially at least partially resected) ofthe patient, and the ankle joint formed thereby potentially articulated,to ensure the particular tibial component 12, talar component 14 and/ortibial insert 16 achieve a stable replacement ankle joint (e.g., the TARprosthesis 10 sufficiently distributes the forces acting through thejoint) that provides for full articulation/motion of the joint (e.g.,the TAR prosthesis 10 does not overstuff or understuff the ankle joint).Further, the TAR guide 100 can facilitate implantation of the tibialcomponent 12 in/on the distal end tibia of the patient, and/orimplantation of the proximal aspect of the talar component 14 in/on thetalus of the patient, in proper positions and orientations (and therebythe proper position and orientation of the corresponding tibial insert16) for the ankle joint of the particular patient. For example, asdescribed further below, the TAR guide 100 may be positioned between thetibia and talus (potentially at least partially resected) of thepatient, and the ankle joint formed thereby potentially articulated, andthe TAR guide 100 utilized to resect or otherwise remove one or moreportions of the tibia and/or talus for engagement and implantation ofthe tibial component 12 in/on the tibia, and/or the talar component 14in/on the talus.

As shown in FIGS. 2-18, the TAR guide 100 includes a tibial trialcomponent 112, a talar/talus trial component 114 and a tibial trialinsert 116. The tibial trial component 112 of the TAR guide 100 maycorrespond, in at least one aspect, to the tibial component 12 of theTAR prosthesis 10. The talar trial component 114 of the TAR guide 100may correspond, in at least one aspect, to the talar component 14 of theTAR prosthesis 100. The tibia trial insert 116 of the TAR guide 100 maycorrespond, in at least one aspect, to the tibia insert 16 of the TARprosthesis 100. For example, the proximal-distal thickness, themedial-lateral width and/or the anterior-posterior size/dimension, shapeand/or orientation of at least one aspect of the tibial trial component112, the talar trial component 114 and the tibial trial insert 116 maycorrespond (e.g., match or closely approximate) to that of the tibialcomponent 12, the talar component 14 and the tibial trial insert 16,respectively. As noted above, differently sized tibial components 12,talar components 14 and tibial trial inserts 16 may be utilized based ona particular patient. As such, the tibial trial component 112, the talartrial component 114 and the tibial trial insert 116 may be configured orprovided in differing sizes that correspond to the differently sizedtibial components 12, talar components 14 and tibial trial inserts 16,respectively. For example, a plurality of tibial trial components 112,talar trial components 114 and tibial trial inserts 116 may beconfigured or provided with differing anterior-posterior lengths,medial-lateral widths and/or proximal-distal thicknesses thereof. Basedon the trialing of one or more tibial trial component 112, one or moretalar trial component 114 and/or one or more tibial trial insert 116, aparticular size of the tibial trial component 112, talar trial component114 and/or tibial trial insert 116 (and thereby corresponding tibialcomponent 12, talar component 14 and tibial trial insert 16) may beselected based on the particular patient/ankle that best suits thepatient/ankle (and utilized to prepare the tibia and/or talus toimplantation of the tibial trial component 112 and talar trial component114, respectively, therein/thereon). The tibial trial component 112, thetalar trial component 114 and the tibial trial insert 116 may comprise aradio radiopaque material such that at least a portion of the componentsare visible under fluoroscopy or other imaging in situ.

The tibial trial component 112 of the TAR prosthesis 100 is configuredto be coupled to a distal tibia (e.g., a resected portion thereof) andbe utilized as a sizing and orientation trial instrument, and/or apunch/drill/cut guide to the distal tibia, for one or more correspondingtibial components 12. As shown in FIGS. 2-18, the tibial trial component112 may comprise a base portion 120 and an arm or wing portion 122. Theproximal-distal thickness, the medial-lateral width and/or theanterior-posterior size/dimension, shape and/or orientation of the baseportion 120 of the tibial trial component 112 may correspond (e.g.,match or closely approximate) to that of the tibial component 12 of theTAR prosthesis 10. The base portion 120 includes a proximal boneengagement surface or side 124 configured to engage/abut the distaltibia (potentially resected) of a patient. In some embodiments, theproximal bone engagement surface 124 of the base portion 120 is convex(e.g., arcuately convex) along the medial-lateral direction, as shown inFIG. 18. In some other embodiments (not shown), the proximal boneengagement surface 124 of the base portion 120 is flat/planar along themedial-lateral direction, as shown in FIG. 18.

The base portion 120 includes at least one through hole or aperture 130that extends through the base portion 120 along the proximal-distaldirection from the proximal bone engagement surface 124 to a distalinsert engagement surface or side 132 that opposes the proximal boneengagement surface 124, as shown in FIGS. 2, 7 and 9-13.

In some embodiments, the base portion 120 includes a plurality ofthrough holes 130. The at least one through hole 130 is configured as aguide hole for a bone removal and/or aperture formation instrument(e.g., a sharp tipped trocar, drill, punch, etc.) to remove portions ofthe distal tibia to accommodate at least one peg of a correspondingtibial component 12 therein. The at least one through hole 130 maythereby correspond to the position/location (and potentially size and/ororientation) of at least one implantable post of a corresponding tibialcomponent 12. For example, in some embodiments, the system 100 mayinclude a distractor that forces at least one projection/pin through theat least one through hole 130 and into the resected distal tibia 2 toform an aperture in the bone that is configured to accept or mate withat least one peg of a corresponding tibial component 12, such as thatdisclosed in U.S. Provisional Patent Application No. 62/898,854 filedSep. 11, 2018 and entitled Distractors Having Attachable Paddles,Impaction Devices, and Methods for Use in Total Ankle Replacement and/orInternational PCT Patent Application filed on Dec. 13, 2019, andentitled Distractors Having Attachable Paddles, Impaction Devices, andMethods for Use in Total Ankle Replacement, which are herebyincorporated herein by reference in their entireties. As anotherexample, in some embodiments, include an impactor tool (in addition to,or instead of, the distractor) that forces at least one projection/pinthrough the at least one through hole 130 and into the resected distaltibia 2 to form an aperture in the bone that is configured to accept ormate with at least one peg of a corresponding tibial component 12, suchas that disclosed in U.S. Provisional Patent Application No. 62/898,854filed Sep. 11, 2018, and entitled Distractors Having Attachable Paddles,Impaction Devices, and Methods for Use in Total Ankle Replacement and/orInternational PCT Patent Application filed on Dec. 13, 2019, andentitled Distractors Having Attachable Paddles, Impaction Devices, andMethods for Use in Total Ankle Replacement.

It is noted that differing tibial trial components 112 may correspond todiffering corresponding tibial components 12 (e.g., differing sizedcomponents), and thereby may include differing numbers, locations and/orconfigurations of the at least one through hole 130 to correspond to theat least one implantable peg of a respective corresponding tibial trialcomponent 112. As shown in FIGS. 2, 7 and 9-13, the illustrativeembodiment includes four through holes 130 comprising an anterior andmedial through hole 130, an anterior and lateral through hole 130, aposterior and medial through hole 130, and a posterior and lateralthrough hole 130.

The proximal bone engagement surface 124 may include at least one slotor indentation 125 extending therein, such as at least one slot that iselongated along the medial lateral direction, as shown in FIGS. 7, 10,12, 14 and 15. The at least one slot 125 may extend at least through theproximal apex or highest surface portion of the bone engagement surface124 such that the at least one slot 125 (i.e., the edges thereof) isvisible when viewed along the medial-lateral direction (e.g., visibleunder fluoroscopy or other imaging in situ), as shown in FIGS. 14 and15. In this way, the at least one slot 125 may be utilized to identifyportions or aspects of the base portion 120 that may not be visible, ormay be difficult to decipher when viewed at least along themedial-lateral direction (e.g., under fluoroscopy or other imaging insitu). In some embodiments, the base portion 120 may include a pluralityof slots 125 in the proximal bone engagement surface 124. For example,the illustrative embodiment includes an anterior slot 125 and aposterior slot 125 that passes through or corresponds to the anteriorthrough holes 125 and the posterior through holes 125, respectively. Asanother example, the illustrative embodiment also includes a centralslot 125 that passes through or corresponds to the center of the baseportion 120 (and thereby the corresponding tibial component 12) alongthe anterior-posterior direction, which may be utilized to align thebase portion 120 to the long and/or mechanical axis of the tibia alongthe anterior-posterior direction. Still further, the illustrativeembodiment also includes at least one posterior end slot 125 that passesthrough a posterior end portion of the base portion 120 that correspondsto at least one posterior end of at least one first “standard”corresponding tibial component 12 and/or tibial insert 16. The posteriorend of the base portion 120 may correspond to the posterior end of atleast one second “long” corresponding tibial component 12 and/or tibialinsert 16. The at least one posterior end slot 125 and the posterior endof the base portion 120 may thereby be utilized to correctly positionthe base portion 120 and/or the tibial component 12 relative to thetibia 2 (e.g., align a center thereof with an axis of the tibia 2 alongthe anterior-posterior direction) and determine an appropriately size(e.g., “standard” or “long”) of the tibial component 12 and/or tibialinsert 16 to be used with the particular tibia 2 (e.g., a tibialcomponent 12 that extends over the maximum area of the tibia 2 todistribute the forces acting through the joint).

As shown in FIGS. 2-18, the arm portion 122 of the tibial component 112extends proximally from the anterior end of the base portion 120. Theproximal end of the arm portion 122 may be wider in the medial-lateraldirection than the distal end thereof. The arm portion 122 includes anadjustment screw 129 threadably extending through an adjustment aperture127 along the anterior-posterior direction, as shown in FIGS. 2-18. Theposition of the adjustment screw 129 relative to the arm portion 122along the anterior-posterior may adjusted by rotation of the adjustmentscrew 129. The anterior-posterior position/location of the adjustmentscrew 129 relative to the arm portion 122 may be adjusted with theposterior tip of the adjustment screw 129 contacting the anterior faceof the tibia 2 proximal to the resected portion thereof (e.g., theanterior crown of the tibia 2), as shown in FIG. 45. In this way, theanterior-posterior position/location of the base portion 120 on thedistal tibia 2 can be adjusted via anterior-posterior adjustment (e.g.,via rotation) of the adjustment screw 129. In some embodiments, theadjustment screw 129 may include a nut or other mechanism thatselectively locks the anterior-posterior position of the adjustmentscrew 129 in at least one direction along the anterior-posteriordirection. The adjustment screw 129 and adjustment aperture 127 may bealigned with, or positioned proximate to, the medial-lateral midline ofthe base portion 120.

As shown in FIGS. 5, 6, 10, 11, 17 and 18, the arm portion 122 of thetibial component 112 may include a plurality of pin apertures 126, 128extending therethrough along the anterior-posterior direction. The pinapertures 126, 128 may be configured to accept a pin, k-wire or otherbone fixation member therethrough and into the tibia 2. For example, theillustrative embodiment of the arm portion 122 includes at least a pairof first pin apertures 126 that are aligned with each other and theanterior-posterior direction (i.e., extend normal to the coronal plane(and parallel to the sagittal plane)), as shown in FIGS. 5, 6, 10, 11,17 and 18. As also shown in FIGS. 5, 6, 10, 11, 17 and 18, theillustrative embodiment of the arm portion 122 includes at least a pairof second pin apertures 128 that converge (or diverge) as the extendposteriorly (i.e., are angled with respect to the sagittal plane). Thepair of first pin apertures 126, and/or the pair of second pin apertures128, may each include a pin aperture positioned on a medial side of themedial-lateral midline of the base portion 120, and a pin aperturepositioned on a lateral side of the medial-lateral midline of the baseportion 120. The first and second pin apertures 126, 128 may beconfigured to house pins or other fixation members extendingtherethrough and into the tibia 2.

The first pin apertures 126 may facilitate insertion of first pins orother fixation members therethrough and into the tibia 2 with theproximal bone engagement surface 124 of the base portion 120 engagedwith the distal end (e.g., resected) of the tibia 2 between the tibia 2and the talus 4 (see FIG. 46). The adjustment screw 129 can then beadjusted to translate the tibial component 112 over the first pins alongthe anterior-posterior to adjust the anterior-posterior position of thebase portion 120 on the distal tibia 2 (e.g., to align the centerthereof, potentially indicated by a slot 125) with the axis of the tibia2. The first pins extending through the first pin apertures 126 maythereby fix the tibial component 112 along the medial-lateral andproximal-distal directions while allowing adjustment of the tibialcomponent 112 (particularly the base portion 120 thereof) along theanterior-posterior direction along the first pins via the adjustmentscrew 129. It is noted that the adjustment screw 129 (which may be fixedvia a nut or other mechanism) may also prevent the tibial component 112from translating posteriorly toward the tibia 2. Once the base portion120 is positioned in a desirable location (e.g., the center thereofaligned with the anatomical and/or mechanical axis of the tibia 2), thesecond pins or other fixation members may be inserted through the secondpin apertures 128 and the tibia 2 to lock the anterior-posteriorposition of the tibial component 112 (and particularly the base portion120 thereof).

The distal insert side 132 of the base portion 120 includes a distalrecessed portion 133, as shown in FIGS. 11, 13 and 17. The recessedportion 133 of the distal insert side 132 engages and couples with thetibial trial insert 116, as shown in FIGS. 3-6. As shown in FIGS. 11 and17, sides of the recessed portion 133 may include an undercut orotherwise be angled toward (or away) the periphery of the base portion120 as they extend proximally to a planar proximal end surface to form asliding dovetail socket or female portion. The recessed portion 133 (andthereby the socket/female portion formed thereby) may be open on oneside thereof. For example, in the illustrative embodiment the recessedportion 133 (and thereby the socket/female portion formed thereby) isopen at the anterior end of the base portion 120 distal to the armportion 122. The proximal end surface of the recessed portion 133 mayinclude a slot or indentation 134, as shown in FIGS. 11 and 14.

The tibial trial insert 116 includes a proximal projection or maleportion 135 on a proximal side thereof, as shown in FIGS. 19, 20, 22, 23and 25-28. The projection 135 of the tibial trial insert 116 isconfigured to mate with the recessed portion 133 of the distal insertside 132 of the base portion 120, as shown in FIGS. 3-6. For example,the sides of the projection 135 may include an undercut or otherwise beangled away (or toward) the periphery of the tibial trial insert 116 asthey extend proximally to a planar proximal end surface to form asliding dovetail male portion. The projection 135 of the tibial trialinsert 116 may include a boss 136, as shown in FIGS. 19, 20, 22, 23 and25-28. The boss 136 is configured to mate within the slot or indentation134.

The proximal projection 135 of the tibial trial insert 116 (e.g., asliding dovetail male portion) may engage the recessed portion 133 ofthe base portion 120 (e.g., a sliding dovetail socket/female portion),as shown in FIGS. 3-6. The proximal projection 135 may slidingly engagethe recessed portion 133 along the anterior-posterior direction, andaccess the recessed portion 133 via the anterior opening thereof. Theconfiguration of the proximal projection 135 and the recessed portion133 may couple or fix the tibial trial insert 116 and the base portion120 of the tibial trial component 112 along the medial-lateral andproximal-distal directions. Alternatively, the base portion 120 mayinclude the projection 135, and the tibial trial insert 116 may includethe recessed portion 133, to couple the base portion 120 and the trialinsert 116 together.

The tibial trial insert 116 and the base portion 120 may be fixed orcoupled along the anterior-posterior direction via the slot 134 withinthe recessed portion 133 of the base portion 120 and the boss 136 of theprojection 135 of the tibial trial insert 116. The tibial trial insert116 may slide posteriorly within the recessed portion 133 (e.g., insitu) until the boss 136 is seated within the slot 134 to selectivelyfix the tibial trial insert 116 and the base portion 120 of the tibialtrial component 112 along the medial-lateral, proximal-distal andanterior-posterior directions. It is also noted that the posterior endof the projection 135 of the tibial trial insert 116 may engage theposterior end of the recessed portion 133 of the base portion 120.

The relative position of the tibial trial insert 116 on the base portion120 along the anterior-posterior direction may be thereby established bythe anterior-posterior location of the boss 136 and/or the posterior endof the projection 135. As shown in FIGS. 4, 19-23, 25 and 26, at leastone of the medial and lateral sides of the tibial trial insert 116 mayinclude a marker or identifier portion 137 that provides a visual (andpotentially tactile) identification of the center of the tibial trialinsert 116 along the anterior-posterior direction. In some embodiments,the marker 137 may extend through the width of the tibial trial insert116 between the medial and lateral sides of the tibial trial insert 116.In some other embodiments, one marker 137 may be positioned on themedial side, and another marker 137 may be positioned on the lateralside, of the tibial trial insert 116. The marker 137 may comprise aradio radiopaque material such the marker visible under fluoroscopy orother imaging in situ. Other portions of the tibial trial insert 116 maycomprise a material that is less visible under fluoroscopy or otherimaging than that of the material forming the marker 137. For example,the portions of the tibial trial insert 116 may be formed ofpolypheylsulfone (e.g., Radel (PPSU)), and the marker 137 may be formedof a metal material.

The marker 137 may be utilized to ensure the center of the tibial trialinsert 116 (and thereby the tibial insert 16 corresponding thereto) isaligned with the anatomical and/or or mechanical axis of the tibia 2.The marker 137 of the tibial trial insert 116 may also be utilized toalign the tibial trial insert 116 (and thereby the tibial insert 16corresponding thereto) appropriately with the mechanical axis of thetalus 4. For example, differing tibial trial inserts 116 may includebosses 136 and/or posterior ends of the projection 135 positioned indifferent anterior-posterior locations (as compared to other portions ofthe tibial trial inserts 116). For example, a “long” tibial trial insert116 (corresponding to a “long” tibial insert 16) may be longer in theanterior-posterior direction than a “short/standard” tibial trial insert116 (corresponding to a “short/standard” tibial insert 16). The boss 136and/or posterior end of the projection 135 of the “long” tibial trialinsert 116 may positioned further posteriorly (and theanterior-posterior center and marker 137 thereby positioned furtheranteriorly) than that of the “short/standard” tibial trial insert 116. A“long” or “short/standard” tibial trial insert 116 may thereby beselected to ensure the tibial trial insert 116 is aligned with theanatomical and/or or mechanical axis of the tibia 2 in theanterior-posterior direction (and the talus 4 is appropriately alignedwith the axis of the talus 4 for a particular patient, as the tibialtrial insert 116 may effectively position, at least in part, the talartrial component 114, and thereby the corresponding talar component 14and talus 4) (i.e., a particular tibia 2 and talus 4).

As shown in FIGS. 4, 19-22, 24-26 and 53-56, the distal side of thetibial trial insert 116 opposing the projection 135 includes at leastone posterior rail portion 142 and at least one anterior rail portion144 that are each extended along the medial-lateral direction and spacedfrom each other along the anterior-posterior direction. The at least oneposterior rail portion 142 and the at least one anterior rail portion144 provide sliding/gliding articulation over an articulation surface146 of the talar trial component 114, and thereby about a point or axisof rotation of the talar trial component 114 (and thereby a point oraxis of a corresponding talar component 14) and/or the talar 4, as shownin FIGS. 2, 4, 53 and 56. In some embodiments, the at least oneposterior rail portion 142 and the at least one anterior rail portion144 provide sliding/gliding articulation over the articulation surface146 of the talar trial component 114 about an axis of rotation of thetalar trial component 114 and/or the talar 4 that extends along themedial-lateral direction (e.g., provides sagittal rotation of the talartrial component 114 over the talar trial component 114), as shown inFIG. 56.

As shown in FIGS. 21, 22, 24 and 54, the tibial trial insert 116 maycomprise a pair of anterior rail portions 144 that are positioned onrespective medial and lateral sides of a strut portion 140 that isextended in the anterior-portion direction to the at least one posteriorrail portion 142. In some other embodiments, the tibial trial insert 116may comprise a single anterior rail portion 144 that is not segmented bythe strut portion 140. The strut portion 140 may extend further distallythan the distal apex of the engagement surface 145 of the anterior railportions 144, as shown in FIGS. 25 and 26. As also shown in FIGS. 25 and26, the engagement surface 145 of the anterior rail portions 144, whichengage and articulate on the articulation surface 146 of the talar trialcomponent 114 as shown in FIG. 56, may be flat or convex (i.e., notconcave). In some embodiments, the engagement surface 143 of theposterior rail portion 142, which engage and articulate on thearticulation surface 146 of the talar trial component 114 as shown inFIG. 56, may be flat or convex (i.e., not concave). In some embodiments,both the engagement surface 143 of the posterior rail portion 142 andthe engagement surface 145 of the anterior rail portions 144 arearcuately convex with the engagement surface 143 of the posterior railportion 142 being defined by a larger radius than a radius defining theengagement surface 145 of the anterior rail portions 144, as shown inFIG. 56. In some examples, the engagement surface 143 of the posteriorrail portion 142 is defined by at least a first radius within the rangeof 3 mm to 10 mm, or more preferably within the range of 3 mm to 5 mm.In some examples, the engagement surfaces 145 of the anterior railportions 144 are arcuately convex and defined by at least one secondradius within the range of 50 mm to 150 mm, or more preferably withinthe range of 100 mm to 110 mm. It is noted that the posterior portion ofthe articulation surface 146 of the talar trial component 114 may beinterrupted by a cut slot 150, as shown in FIGS. 29, 30, 35, 36, 47,49-52, 55 and 56 and described further below. If the engagement surface143 of the posterior rail portion 142 is arcuately convex, theengagement surface 143 may be defined by a radius that is at least twicethe length of the anterior-posterior length of the cut slot 150, such asat least 2.5, 3, 3.5, 4, 4.5 or 5 times the width, so that the anteriorrail portion 145 can articulate over the cut slot 150 without binding orextending within the cut slot 150 such that the articulation isprevented or unsatisfactorily disrupted, as shown in FIG. 56. If theengagement surface 143 of the posterior rail portion 142 is flat (i.e.,planar), the anterior-posterior width of the engagement surface 143 ofthe posterior rail portion 142 may be wider that the anterior-posteriorlength of the cut slot 150, such as at least 1.5 times the length, sothat the posterior rail portion 142 can articulate over the cut slot 150without binding or extending within the cut slot 150 such that thearticulation is prevented or unsatisfactorily disrupted.

As shown in FIG. 53, the anterior rail portion 144 and the posteriorrail portions 142 may be spaced along the anterior-posterior directionsuch that a portion of the height H1 of the articulation surface 146 ofthe talar trial component 114 extends above (e.g., proximally) thepoints of contact between the engagement surfaces 143, 145 and thearticulation surface 146 that allows the tibial trial insert 116 to beinserted between the tibial trial component 112 and the talar trialcomponent 114 in situ and prevents the tibial trial insert 116 from“squeezing” or otherwise being compressed out from the tibial trialcomponent 112 and the talar trial component 114 in situ. In suchembodiments, the posterior rail portion 142 and the anterior railportions 144 may be spaced along the anterior-posterior direction suchthat 2 mm of height H1 of the articulation surface 146 of the talartrial component 114 extends above (e.g., proximally) the points ofcontact between the engagement surfaces 143, 145 and the articulationsurface 146, as shown in FIG. 53. It is noted that differently sizedtalar trial components 114 (corresponding to differently sized trialcomponents 14) may include articulation surfaces 146 defined bydiffering radii, and therefore differently sized tibial trial inserts116 (corresponding to differently sized trial components 14) may includedifferently configured posterior and anterior rail portions 142, 144(e.g., differently spaced along the anterior-posterior direction) suchthat the proper height H1 of the articulation surface 146 (i.e., 2 mm)extends above (e.g., proximally) the points of contact between theengagement surfaces 143, 145 posterior and anterior rail portions 142,144 and the articulation surface 146.

As also shown in FIGS. 4, 19-22, 24-26, 54 and 55, the strut portion 140is extended along the anterior-portion direction. As shown in FIGS. 49,50 and 55, the strut portion 140 seats within a strut slot 148 in thearticulation surface 146 of the talar trial component 114 thatcorresponds to the medial-lateral width, and is at least as deep as thestrut 140 on the proximal-distal direction, of the talar trial component114 to lock relative motion/rotation of the tibial trial insert 116 andthe talar trial component 114 about the inversion-eversion (I-E)direction (i.e., lock inversion-eversion rotation) over the articulationrange of motion. The strut portion 140 and strut slot 148 may therebyalso fix the tibial trial insert 116 and the talar trial component 114along the medial-lateral direction. As shown in FIGS. 21, 22, 24, 54 and55, the strut portion 140 may extend from/past the anterior railportions 144 to an anterior portion of the posterior rail portion 142along the anterior-posterior direction.

As shown in FIGS. 29-36, the posterior end portion of the proximal sideof the talar trial component 114 may include the articulation surface146, the strut slot 148 and the cut slot 150. As noted above, thearticular surface 146 of the tibial trial insert 116 may be convex (inthe anterior-posterior direction), and the posterior and anterior rails142, 144 of the tibial trial insert 116 may engage and articulatethereover via a sliding/gliding motion. The articular surface 146 may bearcuately convex along the anterior-posterior direction, and defined byat least one radius extending from a point or axis of rotation of thecorresponding talar component 14 and/or the talus 4. In someembodiments, the articular surface 146 may be flat/linear in themedial-lateral direction. The at least one radius of the articularsurface 146 may thereby corresponds, approximate or generalize thearticular surface 46 of the corresponding talar component 14. Forexample, the articular surface 146 at least one radius within the rangeof 13 mm to 37 mm, or 18 mm to 22 mm, or 23 mm to 27 mm. In someembodiments, as shown in FIGS. 29-36, the articular surface 146 of thetibial trial insert 116 is defined by a single radius, such as a singleradius within the range of 13 mm to 37 mm, or 18 mm to 22 mm, or 23 mmto 27 mm. It is noted that differently sized talar trial components 114(corresponding to differently sized trial components 14) may includearticulation surfaces 146 defined by differing radii. For example,differently sized talar trial components 114 may include differinganterior-posterior lengths, medial-lateral widths and/or proximal-distalthicknesses. Such differently sized talar trial components 114 may alsoinclude articulation surfaces 146 defined by differing radii, such asradii that differ by ½-2 mm, or by 1 mm, for example (e.g., each withinthe range of 13 mm to 37 mm, or 18 mm to 22 mm, or 23 mm to 27 mm). Insome embodiments, some differently sized talar trial components 114 mayinclude articulation surfaces 146 defined by the same radius.

As shown in FIGS. 29, 30, 35 and 36, the cut slot 150 may extend throughthe talar trial component 114 from the proximal side to the distal sidethereof. The cut slot 150 may be angled posteriorly as is extendsthrough the talar trial component 114 from the proximal side to thedistal side thereof. As explained further below, when a talar engagementsurface portion 151 of the posterior end portion of the distal side ofthe talar trial component 114 engages a resected surface of a portion ofa talus 4, the cut slot 150 may be angled posteriorly as is extendsthrough the talar trial component 114 from the proximal side to thedistal side thereof such that the cut slot 150 can be utilized as a cutguide for the removal of a posterior portion of the talus 4 that extends(and therefore is angled) distally and posteriorly from the resectedproximal surface of the talus 4, as shown in FIGS. 44, 45 and 70-73(when the talar trial component 114 is pinned to the talus 4). The cutslot 150 may extend through an anterior portion of the articulationsurface 146 such that the articulation surface 146 includes a posteriorportion on the posterior side of the cut slot 150 and an anteriorportion on the anterior side of the cut slot 150.

As also shown in FIGS. 29, 30, 35 and 36, the strut slot 148 of thetalar trial component 114 may extend along the anterior-posteriordirection, and potentially through the entirety of theanterior-posterior length of the articulation surface 146. The strutslot 148 may thereby house the strut 140 of the tibial trial insert 116therein over the entire range of motion (e.g., along theanterior-posterior direction) between the talar trial component 114 andthe tibial trial insert 116 to lock relative I-E rotation over theentire range of motion. The strut slot 148 may also extend across thecut slot 150 such that the strut slot 148 includes a posterior portionon the posterior side of the cut slot 150 and an anterior portion on theanterior side of the cut slot 150. The anterior portion of the strutslot 148 may be utilized by one or more cut guide to resect/chamferanterior and/or posterior aspects of the talus 4, as described furtherbelow. The talar trial component 114 may include at least three pinapertures 152, 153 extending therethrough along the proximal-distaldirection, as shown in FIGS. 29, 30, 35 and 36. The pin apertures 152,153 may be configured to accept a pin, k-wire or other bone fixationmember therethrough and into a talus 4. For example, the illustrativeembodiment the talar trial component 114 includes at least a pair offirst pin apertures 152 that converge (or diverge) as the extenddistally (i.e., are angled with respect to the sagittal plane), as shownin FIGS. 35 and 36. As also shown in FIGS. 35 and 36, the illustrativeembodiment of the talar trial component 114 includes at least one secondpin aperture 153 that is positioned anteriorly from the first pinapertures 152. In some embodiments, the talar trial component 114 mayinclude at least a pair of second pin apertures 153 that are positionedanteriorly from the first pin apertures 152. In such embodiments, secondpin apertures 153 may be aligned with each other (i.e., extend parallelon all planes). The pair of first pin apertures 152, and/or the pair ofsecond pin apertures 153 (if provided), may each include a pin aperturepositioned on a medial side of the medial-lateral midline of the talartrial component 114, and a pin aperture positioned on the lateral sideof the medial-lateral midline of the talar trial component 114. Thefirst and second pin apertures 152, 153 may be angled posteriorly asthey extend through the talar trial component 114 from the proximal sidethereto to the distal side thereof.

The first pin apertures 152 may facilitate insertion of first pins orother fixation members therethrough and into the talus 4 with the distalbone engagement surface 151 of the talar trial component 114 engagedwith the proximal end (e.g., resected) of the talus 2 and positionedbetween the tibia 2 and the talus 4 (see FIGS. 60-69) with the talartrial component 114 positioned in a desirable location (e.g., the centerthereof aligned with the anatomical and/or mechanical axis of the tibia2 and/or talus 4), to fix or lock the talar trial component 114 to theresected talus 4 (e.g., along the medial-lateral, proximal-distal andanterior-posterior directions). The at least one second aperture 153 mayalso facilitate insertion of at least one second pin or other fixationmember therethrough and into the talus 4 for a third point of fixationof the talar trial component 114 to the talus 4. Such at least onesecond pin extending through the at least one second aperture 153 mayalso be utilized as a reference pin for furtherprocessing/resecting/cutting the talus 4, such as after removal of thetalar trial component 114 from the talus 4 (e.g., a chamfer cutting jigor other cut guide may utilize the at least one second pin forprocessing/resecting/cutting the talus 4). In some embodiments, thefirst pin apertures 152 and the at least one second pin aperture 153 maybe non-threaded or threaded (e.g., for threaded engagement with abushing or the like). It is noted that the talar trial component 114 andthe talus 4 may need to be placed into plantar flexion to access thefirst pin apertures 152 and/or the second pin apertures 153 in situ(i.e., to translate pins therethrough) (as the tibial component 112, thetibial insert trial 116 and/or anatomical structure(s) of the patientmay block access to the first pin apertures 152 and/or the second pinapertures 153 when the talar trial component 114 and the patient's footis not in plantar flexion.

As shown in FIGS. 29, 30, 35 and 36, the talar trial component 114 mayinclude an anterior window or aperture 154 extending therethrough fromthe proximal side to the distal side thereof. In some embodiments, atleast a portion of the anterior window 154 may be positioned between thefirst pin apertures 152, and the second pin apertures 153, if provided,along the medial-lateral direction. In some embodiments, at least aportion of the anterior window 154 may be positioned between the firstpin apertures 152 and the at least one second pin aperture 153. Asexplained further below, when the talar engagement surface portion 151of the posterior end portion of the distal side of the talar trialcomponent 114 engages a resected surface of a portion of the talus 4,the anterior window 154 may be positioned over the anterior side of thetalus 4 such that the anterior window 154 can be utilized with a cutguide for the removal of an anterior portion of the talus 4 that extends(and therefore is angled) distally and anteriorly from the resectedsurface of the talus 4, as shown in FIGS. 44, 45, 47, 48 and 70-73 (whenthe talar trial component 114 is pinned to the talus 4).

As also shown in FIGS. 29, 30, 35 and 36, the talar trial component 114may include at least one anterior cut guide support surface 155 (whichmay be recessed from the proximal surface of the talar trial component114). The anterior cut guide support surface 155 may be angledanteriorly as it extends partially through the talar trial component 114from the proximal side toward the distal side thereof. The anterior cutguide support surface 155 is positioned anteriorly of at least a portionof the anterior window 154, as shown in FIGS. 29, 30, 35 and 36. Theanterior cut guide support surface 155 may be configured to accept andsupport an anterior cut guide over the anterior window 154. The anteriorcut guide support surface 155 may be configured to prevent movement of acut guide positioned thereon (as explained further below) relative tothe talar trial component 114 along the anterior-posterior direction andthe distal direction (and potentially along the medial-lateraldirection). The anterior end portion of the talar trial component 114may include a manually engageable handle portion 156 that may beutilized to manipulate the talar trial component 114 and the talus 4(i.e., the patients foot), such as plantar and dorsal flexion.

As shown in FIGS. 29, 30, 32, 33, 35, 36, 43, 45, 51, 52, 53, 71 and 73,the distal side of the talar trial component 114 may include at leastone reference slot or indentation 157 extending therein from at leastone of the medial and lateral sides thereof, such as at least onereference slot 157 that is elongated along the medial lateral direction.The at least one reference slot 157 may be visible at least when thetalar trial component 114 is viewed along the medial-lateral direction(e.g., visible under fluoroscopy or other imaging in situ), as shown inFIGS. 31, 43, 45, 71 and 73. In this way, the at least one slot 157 maybe utilized to identify portions or aspects of the talar trial component114 (and/or a corresponding talar component 14) that may not be visible,or may be difficult to decipher, when the talar trial component 114 isviewed at least along the medial-lateral direction (e.g., underfluoroscopy or other imaging in situ). In some embodiments, the talartrial component 114 may include a plurality of reference slots 157 inthe distal side. For example, the talar trial component 114 may includea posterior reference slot 157 that corresponds to the location of oneor more posterior support pegs 19 of a corresponding talar component 14,which may be utilized to align the talar trial component 114 so that theone or more pegs 19 are properly located in the talus 4. In someembodiments, as shown in FIGS. 38, 39 and 41, the talar trial component114 may include an anterior reference slot 157 that corresponds to theposition of an anterior portion of the articulation surface 46 of thecorresponding talar component 14, which may be utilized as a referencefor alignment of the talar trial component 114 so that the anteriorresection of the talus 4 and the corresponding talar component 14 isproperly located (see FIGS. 38, 39 and 41). As another example, theillustrative embodiment also includes a posterior angled reference slot157 that is aligned and corresponds with the posterior cut slot 150,which may be utilized as a reference for alignment of the talar trialcomponent 114 so that the posterior resection of the talus 4 andcorresponding portion 16 of a corresponding talar component 14 isproperly located (see FIGS. 38, 39 and 41). Still further, theillustrative embodiment also includes at least one articulationreference slot 157 that corresponds to the center (e.g., of the radiusor articulation axis of) the articulation surface 146 of the talar trialcomponent 114 (and potentially thereby that of a corresponding tibialcomponent 14) along the anterior-posterior direction, which may beutilized to align articulation surface 146 of the talar trial component114 (and thereby that of the correspond tibial component 14) to themechanical axis of the tibia 2 and/or talus 4 along theanterior-posterior direction. As yet another example, the illustrativeembodiment also includes a posterior angled reference slot 157 that isaligned and corresponds with an anterior resection of the talus 4 via ananterior cut guide 170 and the anterior window 154, which may beutilized as a reference for alignment of the talar trial component 114so that the anterior resection of the talus 4 and corresponding portion13 of a corresponding talar component 14 is properly located (see FIGS.38, 39 and 41).

As shown in FIGS. 37-43, 49 and 50, the articulation surface 146 of thetalar trial component 114 may correspond to a talar component 14 thatincludes an articulation surface 46 that contacts and articulates (viasliding/gliding motion) with that of a corresponding tibial insert 16(see FIG. 1). The articulation surface 46 of the talar component 14 maybe defined by a plurality of radii. The articulation surface 146 of thetalar trial component 114 may approximate or substantially correspond tothe articulation surface 46 of the talar component 14. For example, thearticulation surface 146 of the talar trial component 114 may be definedby a radius extending from an axis of rotation that corresponds to ormatches that of at least one portion of the articulation surface 46 ofthe talar component 14. As another example, the articulation surface 146of the talar trial component 114 may be defined by a radius extendingfrom an axis of rotation that corresponds to an average or generalapproximation of the radii of the articulation surface 46 of the talarcomponent 14. The articulation surface 146 of the talar trial component114 may thereby provide a close approximation of the articulationsurface 46 of the corresponding talar component 14 such that the sizeand range of motion of the corresponding talar component 14 be tested ortrialed via the articulation surface 146 of the talar trial component114 (and the tibial trial insert 114).

As shown in FIGS. 38, 39, 41, the distal side of a talar component 14may be comprised of a plurality of planar surfaces that engage a talus4. For example, a talar component 14 may include a planar posteriorsurface 13, a planar central surface 15 and a planar anterior surface17, as shown in FIGS. 38, 39, 41. The planar posterior surface 13 mayextend posteriorly and distally from the planar central surface 15, andthe planar anterior surface 17 may extend anteriorly and distally fromthe planar central surface 15. The planar anterior surface 17 mayinclude one or more support pegs 19 extending distally therefrom forimplantation into the talus 4.

The talar engagement surface portion 151 of the distal side of the talartrial component 114 may correspond to at least a portion of the planarcentral surface 15 of the talar component 14. In some embodiments, thesize and shape of the talar engagement surface portion 151 of the distalside of the talar trial component 114 matches that of the planar centralsurface 15 of the talar component 14. It is noted that a talus 4 may beresected to form a planar central surface 15′ corresponding to theplanar central surface 15 of the talar component 14 via a guide systemnot disclosed herein, as shown in FIGS. 45, 48 and 70-73.

As shown in FIGS. 45, 48 and 70-73, the talar engagement surface portion151 of the distal side of the talar trial component 114 may bepositioned on (i.e., engage or abut) the resected planar central surface15′ of the talus 4 and utilized to further resect the talus 4 to includea chamfered planar posterior surface 13′ that corresponds to the planarposterior surface 13 of the talar component 14 (via the posterior cutslit 150) and a chamfered planar anterior surface 17′ that correspondsto the planar anterior surface 17 of the talar component 14 (via ananterior cut guide 170 and the anterior window 154), as explainedfurther below.

As shown in FIGS. 44 and 45 and discussed above, the TAR guide 100 maybe utilized with a resected ankle joint of a patient (i.e., between aresected distal tibia 2 and a resected proximal talus 4) to facilitatethe selection of a properly sized tibial component 12, talar component14 and/or tibial insert 16 of a TAR prosthesis 10 based on thesize/configuration of the ankle joint of the particular patient, as wellas facilitate implantation of the tibial component 12 in/on the tibia 2and/or implantation of the talar component 14 in/on the talus 4, inproper positions and orientations (and thereby the proper position andorientation of the corresponding tibial insert 16) for the particularankle joint.

As shown in FIGS. 44-56, the engagement surface 124 of the base portion120 of the tibial trial component 112 may be positioned on the resectedportion of the distal tibia 2 and adjusted into a correct or preferableposition (and/or swapped for a differing sized tibial trial component112), which may be tactically and/or visually (directly or underfluoroscopy or other imaging) determined, as described above. Forexample, the peripheral edges of the tibial trial component 112(including the reference slots 125) may be utilized to position thetibial trial component 112 with respect to the tibia 4. Once properlypositioned, a plurality of pins 160 may be driven through the pinapertures 126, 128 of the arm portion 122 of the tibial trial component112 and into the tibia 2 to fix the tibial trial component 112 to thetibia 2, as shown in FIGS. 57-59. In some embodiments, the plurality ofthrough holes 130 may be utilized to with a cutting instrument (e.g., asharp tipped trocar) to remove portions of the distal tibia 2 forimplantation of at least one peg of the corresponding tibial component12 therein.

With the tibial trial component 112 coupled to the tibia 2, theengagement surface portion 151 of the posterior end portion of thedistal side of the talar trial component 114 may be positioned in theresected surface portion 15′ of the talus 4, as shown in FIGS. 44, 45,47, 48 and 70-73. The size of the tibial trial component 112 may beinspected to determine if the tibial trial component 112 (and therebythe corresponding talar component 14) provides proper coverage of thetalus 4 and is properly positioned, and the anterior and posteriorresected surface portions or chamfers 13′, 17′ formed via cut slot 150and the window 154 of the tibial trial component 112 would be properlypositioned, as described above. Once a proper size of the talar trialcomponent 114 is chosen and properly positioned on the resected talus 4,the tibial trial insert 116 may be inserted between the tibial trialcomponent 112 and the talar trial component 114, as shown in FIGS. 44,45, 60 and 61, as described above. For example, the tibial trial insert116 may be inserted into the recess 133 of the base portion 120 of thetibial trial component 112, as shown in FIGS. 44, 45, 57-61, and theposterior and anterior articulation rails 142, 144 engaged with thearticulation surface 146 of the talar trial component 114, as shown inFIGS. 44, 45, 48-53, 55, 56 and 60. The tibial trial insert 116 and thepatient's foot may then be dorsiflexed and plantar flexed to test ortrial the articulation afforded by the TAR guide system 100 (and therebythe corresponding TAR prosthesis 10), as shown in FIGS. 55 and 56 anddescribed above. Once the proper articulation and soft-tissue balancingprovided by the TAR prosthesis 100 is determined or achieved (e.g., viaselection of differing sized tibial trial inserts 116 (e.g., thicknessesthereof), and the tibial trial insert 116 is properly positioned, aplurality of pins 162 may be driven through the pin apertures 152, 153of the talar trial component 114 and into the talus 2 to fix the tibialtrial component 112 to the tibia 2, as shown in FIGS. 60-69. As notedabove, the patient's foot may need to be plantar flexed to access thepin apertures 152, 153.

With the tibial trial component 112 fixed to the tibia 2 via theplurality of pins 162 driven through the pin apertures 152, 153 and intothe talus 2, the tibial trial component 112 and the tibial trial insert116 may be removed from the ankle joint. The talar trial component 114may then be utilized to form the anterior and posterior resected surfaceportions or chamfers 17′, 13′ via the anterior window 154 and the cutslot 150, respectively. For example, as shown in FIGS. 62-66, ananterior cut guide 170 may be engaged with, or coupled to, the tibialtrial insert 116 via the anterior cut guide support surface 155 and/orthe strut slot 148 such that it extends over the anterior window 154,and thereby over the anterior portion of the talus 4. For example, theanterior cut guide 170 may include an anterior support portion thatseats/engages within/on the anterior cut guide support surface 155,and/or a posterior projection that seats within the strut slot 148. Theanterior cut guide 170 may include one or more apertures 172 extendingtherethrough along the proximal-distal direction that are aligned overthe anterior window 154 and the anterior portion of the talus 4, asshown in FIGS. 62-65. In some embodiments, the anterior cut guide 170includes a plurality of apertures 172, as shown in FIGS. 62-65. Inalternative embodiments, the anterior cut guide 170 includes a singleaperture 172 (not shown).

The cut guide 170 may include an exposed proximal guide surface 174 thatis be planar and angled at an orientation that matches the orientationof the planar anterior surface 17 of the talar component 14, and therebythe desired chamfered planar anterior surface 17′ corresponding thereto.As shown in FIGS. 66 and 70-73, a cutting end of a cutting implement 176may be passed through the at least one aperture 172 of the cut guide170, and a guide surface of the cutting implement 176 (e.g., provided bya shoulder and/or bushing thereof, for example) engaged with the guidesurface 174, to cut/chamfer the anterior portion of the talus 4 and formthe chamfered planar anterior surface 17′ (see FIGS. 70-73). The cuttingimplement 176 may be configured to form a planar cut surface of theanterior portion of the talus 4. In some embodiments, the cuttingimplement 176 may be a one-piece instrument. It is noted that thecutting implement 176 be moved or translated within the at least oneaperture 172 of the cut guide 170, and/or more than one cut guide 170with differing positioned apertures 172 may be utilized, to fully cutthe anterior portion of the talus 4 and form the chamfered planaranterior surface 17′. Further, multiple cutting implements 176 with oneor more one cut guides 170 may be utilized to fully cut the anteriorportion of the talus 4 and form the chamfered planar anterior surface17′.

With the tibial trial component 112 and the tibial trial insert 116removed from the ankle joint and the tibial trial component 112 fixed tothe tibia 2 via the plurality of pins 162 driven through the pinapertures 152, 153 and into the talus 2, the tibial trial insert 116 mayalso be utilized to form the posterior resected surface portion orchamfer 13′ via the posterior cut slot 150 and at least one cuttingimplement 180. For example, as shown in FIGS. 67-69, a posterior cuttingguide 182 may be coupled to the tibial trial insert 116 via the cutanterior cut guide support surface 155 and/or the strut slot 148 (and/oran anterior aperture) such that it extends adjacent (e.g., anteriorly)or over the cut slot 150. In some embodiments, the posterior cuttingguide 182 may be engaged with, or coupled to, the tibial trial insert116 via the anterior cut guide support surface 155 and/or the strut slot148 such that it extends to the posterior cut slot 150. For example, theposterior cutting guide 182 may include an anterior support portion thatseats/engages within/on the anterior cut guide support surface 155,and/or a posterior projection that seats within the strut slot 148. Insome embodiments, the posterior cutting guide 182 may extend over andcover/block off the anterior window 154.

The posterior cut guide 182 may include an exposed guide surface 184that is planar and aligned with the cut slot 150 (e.g., angled at anorientation that matches angle of the cut slot 150), and thereby alignedwith the planar posterior surface 13 of the talar component 14 and thedesired chamfered planar posterior surface 13′ corresponding thereto. Inone alternative embodiment, the posterior cut guide 182 may include anangled slot, as opposed to the planar exposed guide surface 184, that isconfigured to accept the at least one cutting implement 180 therethroughthat is angled at an orientation that matches the orientation of theplanar posterior surface 13 of the talar component 14. As shown in FIGS.67-69, the cutting implement 180 (e.g., a saw blade) may be passedthrough the posterior cut slot 150 of the talar trial component 114, andengaged or rested on the guide surface 184 of the posterior cut guide182, and operated to cut/chamfer the posterior portion of the talus 4 toform the chamfered planar posterior surface 13′ (see FIGS. 70-73).

As shown in FIGS. 70-73, the talar trial component 114 of the TAR guide100 may thereby be utilized to both trial a corresponding talarcomponent 14 of a TAR prosthesis and to form anterior and posteriorresected surface portions or chamfers 17′, 13′ (via the anterior window154 and the anterior cut guide 170, and via the cut slot 150 andposterior cut guide 182, respectively) on the proximal talus 4 forimplantation of the talar component 14 thereon/therein.

FIGS. 74-133 illustrate components of another TAR trial and bonepreparation guide system 200, in accordance with the present disclosure,that is configured to trial, and prepare a resected distal tibia and aresected talus for implantation therein and therebetween, a TARprosthesis comprising a tibial component comprising a tibial engagementsurface with at least one bone engagement projection/peg, a tibialinsert configured to removably couple with the tibial component andcomprising a tibial articulation surface, and a talar componentcomprising a talar engagement surface with at least one bone engagementprojection/peg/fin and a talar articulation surface that articulateswith the tibial articulation surface of the tibial insert. At least somecomponent of the TAR trial and bone preparation guide system 200 ofFIGS. 74-133 are similar to that of the TAR trial and bone preparationguide system 100 of FIGS. 2-73, and therefore like reference numeralspreceded with “2” are used to indicate like components, portions,aspects, features and functions, and the description above directedthereto (including any alternative embodiments thereof) equally appliesto the TAR trial and bone preparation guide system 200 and is notrepeated hereinbelow only for brevity sake.

As shown in FIGS. 74, 76, 77, 85, 86 and 94, the system 200 may includea distractor 217. The distractor 217 may include a first arm 215 and asecond arm 219 that are configured to engage the base portion 220 of thetibial trial guide 212 and the anterior end 258 of the first talar trialguide 214, respectively. For example, the first arm 215 may include atool (e.g., at least one paddle) that presses (directly or indirectly)against the distal side of the base portion 220 of the tibial trialguide 212 and/or forces a projection through bone aperture formationhole(s) 230 thereof (and into the resected distal tibia 2), as shown inFIGS. 74, 76 and 77. As another example, the second arm 219 may couplewith a socket anterior end portion 258 of the of the first talar trialguide 214, as shown in FIGS. 74, 85 and 86. The distractor 217 may beconfigured to be manually manipulated to effectuate movement of thefirst arm 215 and the second arm 258 together and apartanteriorly-posteriorly. The distractor 217 may thereby be utilized toform one or more aperture in the resected distal tibia 2, distract theankle joint, and/or facilitate engagement/coupling of the tibial trialguide 212 with the resected distal tibia 2 and/or the first talar trialguide 214 with the resected talus 4, for example. In some embodiments,the distractor 217 may be a distractor disclosed in U.S. ProvisionalPatent Application No. 62/898,854 filed Sep. 11, 2018 and entitledDistractors Having Attachable Paddles, Impaction Devices, and Methodsfor Use in Total Ankle Replacement and/or International PCT PatentApplication filed on Dec. 13, 2019, and entitled Distractors HavingAttachable Paddles, Impaction Devices, and Methods for Use in TotalAnkle Replacement.

As shown in FIGS. 78-84, the tibial trial guide 212 of the system 200may differ from the tibial trial guide 112 with respect to theconfiguration of the second pin apertures 228. As shown in FIGS. 78-84,the medial and lateral wings of the arm portion 222 may each include apair of second pin apertures 228 that are proximally-distally spaced. Itis noted that in some embodiments, a proximal second pin aperture 228and a distal second pin aperture 228 of the medial and lateral (orlateral and medial) wing portions may be utilized via pin members 260(e.g., shoulder pins) to couple the tibial trial guide 212 to theresected distal tibia 2.

As also shown in FIGS. 78-84, the tibial trial guide 212 may differ fromthe tibial trial guide 112 with respect to the configuration of thefirst pin apertures 226. As shown in FIGS. 78-84, the arm portion 222may include a pair of medially-laterally spaced proximally-distallyelongated or oblong first pin apertures 228 and a pair ofmedially-laterally spaced circular first pin apertures 228. The pair ofmedially-laterally spaced proximally-distally elongated or oblong firstpin apertures 228 may converge medially-laterally as they extendposteriorly. The pair of medially-laterally spaced proximally-distallyelongated or oblong first pin apertures 228 may be configured to acceptpin members 260 (e.g., threaded shoulder pins) therethrough and into theresected distal tibia 2 to couple the tibial trial guide 212 to theresected distal tibia 2. The pair of medially-laterally spaced circularfirst pin apertures 228 may be aligned and configured to accept pinmembers 260 (e.g., smooth Steinmann pins) therethrough and into theresected distal tibia 2 to couple the tibial trial guide 212 to theresected distal tibia 2. It is noted that in some embodiments only themedial first pin aperture 228 of the pair of medially-laterally spacedcircular first pin apertures 228 may be utilized with a pin member 260.

As further shown in FIGS. 78-84, the tibial trial guide 212 may differfrom the tibial trial guide 112 with respect to the configuration of theanterior-posterior adjustment screw mechanism 229. As shown in FIGS.78-84, the adjustment screw mechanism 229 may include a double nutconfiguration to lock the anterior-posterior position of the adjustmentscrew mechanism 229 within the arm portion 222. As also shown in FIGS.78-84, the adjustment screw mechanism 229 may include an anti-removalmember or feature that prevents the adjustment screw 229 fromdisengaging from the arm portion 222.

As further shown in FIGS. 78-84, the tibial trial guide 212 may differfrom the tibial trial guide 112 with respect to the configuration of theat least one through hole 230 of the base portion 220. As shown in FIGS.78-84, the base portion 220 only includes a pair of medially-laterallyspaced (anteriorly-posteriorly aligned) through holes 230 between theanterior-posterior center and posterior end of the base portion 220.Further, the recessed portion 233 of the distal insert side 232 of thebase portion 220 may be void of a slot or indentation, as shown in FIGS.79 and 81.

As shown in FIGS. 87-95, the first talar trial guide 214 of the system200 may differ from the talar trial guide 114 with respect to theconfiguration of the articulation surface 246. As shown in FIGS. 87-95,the articulation surface 246 comprises a smooth anteriorly-posteriorlyarcuately convex surface that extends medially-laterally at least acrossthe medial-lateral centerline of the first talar trial guide 214. Inthis way, the articulation surface 246 is thereby void of aanteriorly-posteriorly extending slot (or projection). In someembodiments, the articulation surface 246 may be defined by a singleradius, as shown in FIG. 91. In some other embodiments, the articulationsurface 246 may be defined by a plurality of differing radii. In someembodiments, the articulation surface 246 may be flat or linearmedially-laterally.

It is noted that although the articulation surface 246 may correspond orapproximate to the articulation surface of the 46 of the tibial insert14, a tibial trail insert 216 (see FIGS. 116-119) may not be insertedbetween the tibial trial guide 112 and the first talar trial guide 214and trialed, as discussed above with respect to system 100. Rather, thearticulation surface 246 (and the reference lies/slots 257) may only bevisually utilized to trial/examine the size, position an and orientationof the tibial insert 14. However, in some other embodiments the tibialtrail insert 216 (see FIGS. 116-119) may be inserted between the tibialtrial guide 112 and the first talar trial guide 214 and trialed, asdiscussed above with respect to system 100.

As discussed above and also shown in FIGS. 87-95, the first talar trialguide 214 of the system 200 may differ from the talar trial guide 114with respect to the configuration of the anterior end portion 258. Asshown in FIGS. 87-95, the anterior end portion 258 is configured as asocket (or projection) that mates with (i.e., accepts therein) a tool oran arm of the distractor 217. As shown in FIGS. 86 and 88, the anteriorend portion 258 may include a socket with a key-hole shaped slot oropening configured to removably couple the anterior end portion 258 to atool or an arm of the distractor 217.

As shown in FIGS. 87-95, in some embodiments the multi-aperture boneremoval guide 270 that is configured to couple to the support surface(s)255 of the first talar trial guide 214 may include an elongated handleportion 275 that may be manually stabilized during use to keep the boneremoval guide 270 firmly seated on the support surface(s) 255 of thefirst talar trial guide 214. Similarly, as shown in FIG. 99, thesingle-aperture bone removal guide 270′ may include an elongated handleportion 275 that may be manually stabilized during use to keep the boneremoval guide 270′ firmly seated on the support surface(s) 255 of thefirst talar trial guide 214.

With reference to FIGS. 100-103, in some embodiments the system 200 mayinclude a chamfer checker tool or instrument 231 that is configured toaide in ensuring the resected planar central surface 15′, the chamferedplanar posterior surface 13′ (formed via the cut clot 250 of the firsttalar trial guide) and the chamfered planar anterior surface 17′ (formedvia the anterior window 254 of the first talar trial guide 214) of theresected talus 4 properly correspond (or match-up) with the planarcentral surface 15, the planar posterior surface 13 and the planaranterior surface 17, respectively, of the talar component 14 (see, FIGS.38, 39 and 41). As shown in FIGS. 100-103, the chamfer checker tool 231includes a handle portion 138 and an end portion 239. As shown in FIGS.100-103, the end portion 239 of the chamfer checker tool 231 includes aplanar central surface 241, a chamfered planar posterior surface 249extending from the posterior end of the central surface 241, and achamfered planar anterior surface 247 extending from the anterior end ofthe central surface 241 that correspond (or match) the planar centralsurface 15, the planar posterior surface 13 and the planar anteriorsurface 17, respectively, of the talar component 14 (see, FIGS. 38, 39and 41).

As shown in FIGS. 100-103, the end portion 239 of the chamfer checkertool 231 further includes a center reference slot 257 that extendsmedially-laterally through the anterior-posterior center of the centralsurface 241, and thereby correspond to the anterior-posterior center ofthe central surface 241, the talar component 14 (and potentially theaxis and/or anterior-posterior center of the talus 4 and/or tibia 2).The center reference slot 257 can thereby be utilized to visuallyinspect the anterior-posterior position of the talar component 14 whenimplanted on the talus 4.

The end portion 239 of the chamfer checker tool 231 may further includea pair of reference apertures 256, as shown in FIGS. 100-103. Thereference apertures 256 may extend medially-laterally through the endportion 239 proximally of the central surface 241. The referenceapertures 256 may be arranged such that a first reference aperture 256is positioned tangent to a reference line extending along the chamferedplanar posterior surface 249, and a second reference aperture 256 ispositioned tangent to a reference line extending along the chamferedplanar anterior surface 247, as shown in FIG. 103. The referenceapertures 256 can thereby be utilized to visually inspect the positionand orientation of the talar component 14 when implanted on the talus 4.

FIGS. 104-106 illustrate another chamfer checker tool or instrument 331that may be included in or utilized with the system 200. The chamferchecker tool 331 is similar to the chamfer checker tool 231 of FIGS.100-103, and therefore like reference numerals preceded with “3” asopposed to “2” are used to indicate like components, portions, aspects,features and functions, and the description above directed thereto(including any alternative embodiments thereof) equally applies to thechamfer checker tool 331 and is not repeated hereinbelow only forbrevity sake.

As shown in FIGS. 104-106, chamfer checker tool or instrument 331differs from chamfer checker tool or instrument 331 in that it includesan anterior end portion 339A with a first central surface 241A and thechamfered planar anterior surface 247, and a posterior end portion 339Bthat with a second central surface 241B and the chamfered planarposterior surface 249. The handle portion 338 extends between theanterior end portion 339A and the posterior end portion 339B. Theanterior end portion 339A can thereby be utilized to inspect/test thearrangement and configuration of the resected planar central surface 15′and the chamfered planar anterior surface 17′, and the posterior endportion 339B can thereby be utilized to inspect/test the arrangement andconfiguration of the resected planar central surface 15′ and thechamfered planar posterior surface 13′.

With reference to FIGS. 107-109, in some embodiments the system 200 mayinclude a second talar trial guide 290 that is utilized with the tibialtrial guide 212 and a tibial trial insert 216 after the resected talus 4is chamfered via the first tibial trial guide 214 (i.e., after formationand inspection/trialing of the resected planar central surface 15′, thechamfered planar posterior surface and the chamfered planar anteriorsurface 17′ of the resected talus 4, as described above). As describedabove, the proximal projection 235 on the proximal side of the tibialtrial insert 216 may be mated with the distal recessed portion or slot233 of the distal insert side 232 of the base portion 220 of the tibialtrial guide 212 to couple the tibial trial insert 216 to the tibialtrial guide 212 within the ankle joint between the resected distal tibia2 and the resected and chamfered talus 4 (the tibial trial guide 212 maybe previously coupled to the resected distal tibia 2 as describedabove).

The second talar trial guide 290 may also be positioned within the anklejoint between the resected distal tibia 2 and the resected and chamferedtalus 4 such that the second talar trial guide 290 engages the resectedand chamfered talus 4 and the tibial trial insert 216. As shown in FIGS.110-119, the articulation surface 291 of the second talar trial guide290 may engage and articulate with the articulation surface 243 of thetibial trial insert 216 to trial the tibial trial insert 216 (i.e., thetibial insert 16 corresponding thereto).

As described above, the configuration of the tibial trial insert 216 maycorrespond/match or closely approximate that of the tibial insert 16 ina mirrored relationship. For example, as shown in FIGS. 116-120, thearticulation surface 243 of the tibial trial insert 216 may includemedial and lateral surface portions that are medially-laterally andanteriorly-posteriorly arcuately concave, and an anteriorly-posteriorlyarcuately concave and medially-laterally convex medial surface portionthat extends medially-laterally between the medial and lateral surfaceportions. The articulation surface 46 of the tibial insert 16 maythereby be correspondingly or approximately likewise configured (in aproximally-distally mirrored relationship).

To allow the tibial trial insert 216 (and thereby the tibial insert 16)to be trialed in the ankle joint prior to the aperture formation in theresected and chamfered talus 4 that accept the bone engagementprojection(s) 19 of the tibial insert 16), the articulation surface 291of the second talar trial guide 290 may also correspond/match or closelyapproximate that of the tibial insert 16 and/or that of the talarimplant 14. For example, as shown in FIGS. 111-113 and 115 thearticulation surface 291 of the second talar trial guide 290 may includemedial and lateral surface portions that are medially-laterally andanteriorly-posteriorly arcuately convex, and an anteriorly-posteriorlyarcuately convex and medially-laterally concave medial surface portion292 that extends medially-laterally between the medial and lateralsurface portions. The articulation surface 46 of the tibial insert 16may thereby be correspondingly or approximately likewise configured (ina proximally-distally mirrored relationship). The articulation surface291 of the second talar trial guide 290 and the articulation surface 243of the tibial trial insert 216 may thereby mate and articulate with eachother in the same or substantially similar fashion as the talar implant14 and the tibial insert 16 of the TAR prosthesis that they correspondto.

As shown in FIGS. 113 and 114, the distal engagement side 296 of thesecond talar trial guide 290 may include a plurality of planar surfaceportions that correspond to surfaces of the talar engagement side of thetalar component 14. For example, the distal engagement side 296 of thesecond talar trial guide 290 may include a planar central surfaceportion 293, a planar posterior surface 296 and a planar anteriorsurface 294 that correspond to the planar central surface 15, the planarposterior surface 13 and the planar anterior surface 17, respectively,of the talar component 14, as shown in FIGS. 113 and 114. As also shownin FIGS. 113 and 114, the distal engagement side 296 of the second talartrial guide 290 may include a center reference slot 295 that extendsmedially-laterally through the planar central surface portion 293, andthereby corresponds to the anterior-posterior center of the planarcentral surface portion 293, the second talar trial guide 290 and/or thecorresponding talar component 14 (and potentially the axis and/oranterior-posterior center of the talus 4 and/or tibia 2). The centerreference slot 295 can thereby be utilized to visually inspect theanterior-posterior position of the second talar trial guide 290 whenpositioned on the talus 4, as shown in FIGS. 120, 124 and 125.

The second talar trial guide 290 may also include a plurality of pinapertures 297 extending proximally-distally through the second talartrial guide 290. For example, as shown in FIGS. 112, 113, 115 and120-125, the second talar trial guide 290 may include at least a pair ofanterior pin apertures 297 that extend through an anterior end portionthereof from the articulation surface 291 to the planar anterior surface294. As shown in FIGS. 122 and 123, in some embodiments the pair ofanterior pin apertures 297 may be configured to accept pin members 288(e.g., smooth and/or shoulder pins) therethrough and into the anteriorchamfer portion 17′ of the resected talus 4 to couple the second talartrial guide 290 to the resected distal tibia 2, as shown in FIGS. 120,124 and 125. As shown in FIGS. 122 and 123, in some embodiments the pairof anterior pin apertures 297 (and thus the pin members 288 extendingtherethrough) may converge medially-laterally as they extend distallyfrom the second talar trial guide 290.

As also shown in FIGS. 112, 113, 115 and 120-125, the anterior portionof the second talar trial guide 290 may also include a guide recess 299,at least one guide aperture 298 and at least one bone aperture formationguide through hole 201. The recess 299, at least one guide aperture 298and/or the bone aperture formation guide through hole 201 may bepositioned medially-laterally between the pair of anterior pin apertures297. As shown in FIGS. 112 and 115, in some embodiments the anteriorportion of the second talar trial guide 290 may also include a pair ofmedially-laterally spaced guide apertures 298 that are positioned, atleast partially, within the guide recess 299. In some such embodiments,the at least one bone aperture formation guide through hole 201 may bepositioned medially-laterally between the pair of guide apertures 298.

As also shown in FIGS. 112 and 115, in some embodiments the at least onebone aperture formation guide through hole 201 may comprise one or morethrough holes that are anteriorly-posteriorly elongated or oblong. Theposition, size and orientation of the at least bone aperture formationguide through hole 201 may correspond to that of the at least one boneengagement projection 19 of the corresponding talar component 14. Forexample, the corresponding talar component 14 may include a single finprojection 15 that is anteriorly-posteriorly elongated or oblong, andthe at least one bone aperture formation guide through hole 201 maycomprise a corresponding single anteriorly-posteriorly elongated oroblong aperture. In some other embodiments, the corresponding talarcomponent 14 may include a plurality of cylindrical/circular orirregular shaped projections 15, and the at least one bone apertureformation guide through hole 201 may comprise a plurality ofcorresponding cylindrical/circular or irregular shaped projections 15.

With reference to FIGS. 121-125, the system 200 may include a secondtalar trial guide bone aperture formation guide 287 configured to matewith the recess 299 and the at least one guide aperture 298 of thesecond talar trial guide 290 and a bone aperture formation instrument(e.g., a reamer) to form at least one aperture in the resected talus 4(such as in the anterior chamfer portion 17′ thereof) that correspondsto the bone engagement projection(s) 15 of the talar engagement side(e.g., such as the planar anterior surface 17 thereof) of the talarcomponent 14.

As shown in FIGS. 121-125, the second talar trial guide bone apertureformation guide 287 may include a handle portion 283 and a head portion289 that includes at least one second bone aperture formation guidethrough hole 201B. The head portion 289 is configured to mate/nextwithin the guide recess 299, and includes at least one guide projectionthat is configured to extend into the at least one guide aperture 298,such that the at least one second bone aperture formation guide throughhole 201B is aligned with or at least overlaps the at least one boneaperture formation guide through hole 201 of the second talar trialguide 290. In some embodiments, the head portion 289 may include atleast one threaded guide projection that is configured to threadablycouple with a threaded aperture of the at least one guide aperture 298.In some embodiments, the head portion 289 may include at least onenon-threaded guide projection that is configured to couple with anon-threaded aperture of the at least one guide aperture 298.

As shown in FIGS. 123-125, the at least one second bone apertureformation guide through hole 201B is configured to accept a boneaperture formation instrument 276 therein such that the bone apertureformation instrument 276 (e.g., a reamer) forms at least one aperture inthe resected talus 4 (such as in the anterior chamfer portion 17′thereof) that corresponds to the bone engagement projection(s) 15 of thetalar engagement side (e.g., such as the planar anterior surface 17thereof) of the talar component 14. In some embodiments, the at leastone second bone aperture formation guide through hole 201B may beconfigured to allow the bone aperture formation instrument 276 totranslate anteriorly-posteriorly therein (and in the at least one boneaperture formation guide through hole 201 of the second talar trialguide 290) to form an anteriorly-posteriorly elongated or oblongaperture in the resected talus 4 (such as in the anterior chamferportion 17′ thereof) that corresponds to at least one bone engagementfin 15 of the talar engagement side (e.g., such as the planar anteriorsurface 17) of the talar component 14.

In some embodiments, the system 200 may include a third talar trialguide 400 that is configured to trial a tibial trial insert 16 and format least one aperture in a resected talus 4 that does not include thechamfered anterior and posterior surfaces (e.g., include a planar orflat proximal resected surface) for the implantation/engagement of acorresponding talar implant that includes a planar or flat talarengagement surface (not shown), as shown in FIGS. 126-133. As shown inFIGS. 128, 130, 132 and 133, the third talar trial guide 400 may includea planar distal talar bone engagement surface portion 418 that isconfigured to engage/abut the planar resected talus. As shown in FIGS.128, 130, 132 and 133, the third talar trial guide 400 may also includea medially-laterally extending center reference slot 420 that representsthe anterior-posterior center of a tibial trial insert articulationsurface 404 of the third talar trial guide 400 and/or the correspondingtalar implant.

As shown in FIGS. 126-133, the third talar trial guide 400 may includean anterior end portion 416 configured as a socket (or projection) thatis configured to couple with an arm of the distractor 217. In some otherembodiments, the anterior end portion 416 of the third talar trial guide400 may be configured as a manually engageable handle.

As shown in FIGS. 126-133, the third talar trial guide 400 may include apair of medially-laterally spaced anterior first pin apertures 414 thatextend through the third talar trial guide 400 proximally-distally. Thepair of first pin apertures 414 may be configured to accept pin members424 (e.g., smooth pins) therethrough and into the flat resected talus 4.In some embodiments, the pair of first pin apertures 414 (and therebythe pin members 424 extending therethrough) may be aligned and/ororiented vertically, as shown in FIGS. 127 and 128.

As also shown in FIGS. 126-133, the third talar trial guide 400 mayinclude a pair of medially-laterally spaced anterior second pinapertures 412 that extend through the third talar trial guide 400proximally-distally. The pair of second pin apertures 412 may beconfigured to accept pin members 422 (e.g., threaded shoulder pins)therethrough and into the flat resected talus 4. In some embodiments,the pair of second pin apertures 412 (and thereby the pin members 422extending therethrough) may be angled posteriorly and/or convergemedially-laterally as they extend distally, as shown in FIGS. 127 and128.

In some embodiments, the third talar trial guide 400 may include awindow aperture 410 that extends through the third talar trial guide 400proximally-distally, as shown in FIGS. 126-133. In some embodiments, thewindow 410 may be positioned, at least partially, medially-laterallybetween the pair of first pin apertures 414 and/or between the pair ofsecond pin apertures 412. In some embodiments, the window 410 may bepositioned, at least partially, anteriorly-posteriorly between theanterior end portion 416 and the tibial trial insert articulationsurface 404 of the third talar trial guide 400.

To allow the tibial trial insert 216 (and thereby the tibial insert 16)to be trialed in the ankle joint prior to the aperture formation in theflat resected talus 4 that accept the bone engagement projection(s) 19of the tibial insert 16), the articulation surface 404 of the thirdtalar trial guide 400 may correspond/match or closely approximate thatof the tibial insert 16 and/or that of the talar implant. For example,as shown in FIGS. 129 and 131, the articulation surface 404 of the thirdtalar trial guide 400 may include medial and lateral surface portionsthat are medially-laterally and anteriorly-posteriorly arcuately convex,and an anteriorly-posteriorly arcuately convex and medially-laterallyconcave medial surface portion 406 that extends medially-laterallybetween the medial and lateral surface portions. The articulationsurface 46 of the tibial insert 16 may thereby be correspondingly orapproximately likewise configured (in a proximally-distally mirroredrelationship). The articulation surface 404 of the third talar trialguide 400 and the articulation surface 243 of the tibial trial insert216 may thereby mate and articulate with each other in the same orsubstantially similar fashion as the talar implant and the tibial insert16 of the TAR prosthesis that they correspond to.

As shown in FIGS. 126-133, the third talar trial guide 400 may includeat least one bone aperture formation guide through hole 408 that extendsthrough the third talar trial guide 400 proximally-distally. In someembodiments, the at least one bone aperture formation guide through hole408 comprises a pair of medially-laterally spaced bone apertureformation guide through holes 408, which may be angled posteriorly asthen extend distally, as shown in FIGS. 126-133. In some embodiments,the at least one bone aperture formation guide through hole 408 mayextend through an anterior portion of the articulation surface 243, asshown in FIGS. 126-133.

As shown in FIGS. 126-128, the at least one bone aperture formationguide through hole 408 is configured to accept a bone aperture formationinstrument 430 (e.g., a reamer) therein such that the bone apertureformation instrument 430 forms at least one aperture in the resectedtalus (such as in an anterior portion thereof) that corresponds to thebone engagement projection(s) of the talar engagement side of the talarcomponent that corresponds to the articulation surface 404 of the thirdtalar trial guide 400.

The above disclosure describes a portion of a total ankle replacement(TAR) procedure and aspects, devices and systems used in that procedure.Additional understanding of the TAR procedure and the aspects, devicesand systems may be found in U.S. Provisional Patent Application No.62/779,436, filed Dec. 13, 2018, and entitled Joint Replacement Systemsand Methods of Use and Assembly, International PCT Patent ApplicationNo. PCT/US2019/029009, filed Apr. 24, 2019, and entitled Implants andMethods of Use and Assembly, U.S. Provisional Patent Application No.62/779,092, filed Dec. 13, 2018, and entitled Instruments, Guides andRelated Methods for Total Ankle Replacement, the International PCTPatent Application filed on Dec. 13, 2019, and entitled Instruments,Guides and Related Methods for Total Ankle Replacement, U.S. ProvisionalPatent Application No. 62/890,611, filed Aug. 22, 2019, and entitledPatient Specific Instruments and Methods of Use, International PCTPatent Application No. PCT/US2019/066336, filed Dec. 13, 2019, andentitled Patient Specific Instruments and Methods of Use, U.S.Provisional Patent Application No. 62/899,703, filed Sep. 12, 2019, andentitled Joint Replacement Alignment Guides, Systems and Methods of Useand Assembly, the International PCT Patent Application filed on Dec. 13,2019, and entitled Joint Replacement Alignment Guides, Systems andMethods of Use and Assembly, U.S. Provisional Patent Application No.62/899,655, filed Sep. 12, 2019, and entitled Alignment Instruments andMethods for Use in Total Ankle Replacement, International PCT PatentApplication No. PCT/US2019/066149, filed Dec. 13, 2019, and entitledAlignment Instruments and Methods for Use in Total Ankle Replacement,U.S. Provisional Patent Application No. 62/899,740, filed Sep. 12, 2019,and entitled Joint Replacement Alignment Guides, Systems and Methods ofUse and Assembly, International PCT Patent Application No.PCT/US2019/066393, filed Dec. 13, 2019, and entitled Joint ReplacementAlignment Guides, Systems and Methods of Use and Assembly, U.S.Provisional Patent Application No. 62/898,615, filed Sep. 11, 2019, andentitled Resection Guides, Sweeping Reamers, and Methods for Use inTotal Ankle Replacement, International PCT Patent Application No.PCT/US2019/064948, filed Dec. 6, 2019, and entitled Resection Guides,Sweeping Reamers, and Methods for Use in Total Ankle Replacement, U.S.Provisional Patent Application No. 62/898,854, filed Sep. 11, 2019, andentitled Distractors Having Attachable Paddles, Impaction Devices, andMethods for Use in Total Ankle Replacement, International PCT PatentApplication No. PCT/US2019/066398, filed Dec. 13, 2019, and entitledDistractors Having Attachable Paddles, Impaction Devices, and Methodsfor Use in Total Ankle Replacement, U.S. Provisional Patent ApplicationNo. 62/899,646, filed Sep. 12, 2019, and entitled Trial Insert Assembly,International PCT Patent Application No. PCT/US2019/065025, filed Dec.6, 2019, and entitled Trial Insert Assembly, U.S. Provisional PatentApplication No. 62/899,460, filed Sep. 12, 2019, and entitled TotalAnkle Replacement Surgical Method, and the International PCT PatentApplication filed on Dec. 13, 2019, and entitled Total Ankle ReplacementSurgical Method, which are each hereby incorporated herein by referencein their entireties.

As may be recognized by those of ordinary skill in the art based on theteachings herein, numerous changes and modifications may be made to theabove-described and other embodiments of the present disclosure withoutdeparting from the scope of the disclosure. The components of theinstruments, guides, systems and related methods as disclosed in thespecification, including the accompanying abstract and drawings, may bereplaced by alternative component(s) or feature(s), such as thosedisclosed in another embodiment, which serve the same, equivalent orsimilar purpose as known by those skilled in the art to achieve thesame, equivalent or similar results by such alternative component(s) orfeature(s) to provide a similar function for the intended purpose. Inaddition, the instruments, guides, systems and related methods (andcomponents thereof) may include more or fewer components or featuresthan the embodiments as described and illustrated herein. Accordingly,this detailed description of the currently-preferred embodiments is tobe taken in an illustrative, as opposed to limiting of the disclosure.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the disclosure.As used herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprise” (andany form of comprise, such as “comprises” and “comprising”), “have” (andany form of have, such as “has”, and “having”), “include” (and any formof include, such as “includes” and “including”), and “contain” (and anyform of contain, such as “contains” and “containing”) are open-endedlinking verbs. As a result, a method or device that “comprises,” “has,”“includes,” or “contains” one or more steps or elements possesses thoseone or more steps or elements, but is not limited to possessing onlythose one or more steps or elements. Likewise, a step of a method or anelement of a device that “comprises,” “has,” “includes,” or “contains”one or more features possesses those one or more features, but is notlimited to possessing only those one or more features. Furthermore, adevice or structure that is configured in a certain way is configured inat least that way, but may also be configured in ways that are notlisted.

The disclosure has been described with reference to the preferredembodiments. It will be understood that the architectural andoperational embodiments described herein are exemplary of a plurality ofpossible arrangements to provide the same general features,characteristics, and general system operation. Modifications andalterations will occur to others upon a reading and understanding of thepreceding detailed description. It is intended that the disclosure beconstrued as including all such modifications and alterations.

What is claimed is:
 1. A total ankle replacement (TAR) trial and bonepreparation guide system, comprising: a tibial trial and bonepreparation first component comprising: a base portion comprising afirst side with a first tibial engagement surface configured to engage aresected distal tibia and at least one bone aperture formation guidethrough hole extending from the first tibial engagement surface to asecond tibial insert engagement side; and an arm portion extendingproximally from an anterior portion of the base portion configured toengage an anterior side of the resected distal tibia; a talar trial andbone preparation second component comprising: a first talar engagementsurface on a distal side of the second component configured to engage aportion of a resected talus; a posterior trial articulation surface on aproximal side of the second component that is anteriorly-posteriorlyarcuately convex; an anterior window extending through the secondcomponent between the proximal side and the distal side thereof; aposterior cut slot extending through the second component between theproximal side and the distal side thereof that is angled posteriorly asin extends from the proximal side to the distal side; and a plurality ofpin apertures extending through the second component between theproximal side and the distal side; and a talar chamfer trial comprising:a second talar engagement surface on a distal side of the talar chamfertrial configured to engage the resected talus; a second posterior trialarticulation surface on a proximal side of the talar chamfer trial thatcomprises an anteriorly-posteriorly and medially-laterally arcuatelyconvex portion; at least one bone aperture formation guide through hole;and a plurality of pin through holes extending between the proximal anddistal sides of the talar chamfer trial, wherein at least a portion ofthe second posterior trial articulation surface corresponds in size andshape to at least a portion of a second tibial engagement surface of atibial component of a TAR prosthesis, wherein the second talarengagement surface comprises a first planar surface for engaging aplanar surface of the resected talus, a second planar surface extendinganteriorly from the first planar surface on a distal angle configured toengage an anterior chamfer surface of the resected talus formed via theanterior window of the second component, and a third planar surfaceextending posteriorly from the first planar surface on a distal angleconfigured to engage a posterior chamfer of the resected talus formedvia the cut slot of the second component, and wherein the at least onebone aperture formation guide through hole of the talar chamfer trialcomprises an elongated slot at an anterior end portion of the talarchamfer trial that extends through the second planar surface.
 2. Thesystem according to claim 1, further comprising a tibial trial insertcomprising a distal side with a first talar trial engagement surfacethat is configured to engage the posterior trial articulation surface ofthe second component, and a proximal side configured to removably couplewith the second tibial insert engagement side of the first component. 3.The system according to claim 2, wherein the second tibial insertengagement side of the first component comprises a coupling slot, andwherein the tibial trial insert comprises a coupling projectionconfigured to removably mate within the coupling slot.
 4. The systemaccording to claim 3, wherein the coupling slot and the couplingprojection extend and are elongated anteriorly-posteriorly.
 5. Thesystem according to claim 2, wherein the first talar trial engagementsurface is arcuately concave anteriorly-posteriorly.
 6. The systemaccording to claim 1, wherein the system is configured to trial, andprepare the resected distal tibia and the resected talus forimplantation therein and therebetween, a TAR prosthesis comprising atibial component comprising a second tibial engagement surface and atleast one bone engagement projection, a tibial insert configured toremovably couple with the tibial component and comprising a secondtibial articulation surface, and a talar component comprising a thirdtalar engagement surface and a talar articulation surface thatarticulates with the second tibial articulation surface.
 7. The systemaccording to claim 6, wherein the configuration of the first talar trialengagement surface corresponds to at least a portion of the secondtibial articulation surface.
 8. The system according to claim 6, whereinat least a portion of the first tibial engagement surface corresponds insize and shape to at least a portion of the second tibial engagementsurface.
 9. The system according to claim 6, wherein the posterior trialarticulation surface corresponds in size and shape to at least a portionof the talar articulation surface of the talar component.
 10. The systemaccording to claim 1, wherein the first tibial engagement surface isconvex medially-laterally.
 11. The system according to claim 1, whereinthe first side of the base portion of the first component includes atleast one reference slot extending medially-laterally through at least aportion of the first tibial engagement surface.
 12. The system accordingto claim 11, wherein the at least one reference slot comprises at leastone of: a center reference slot positioned in the medial-lateral centerof the base portion corresponding to the medial-lateral center of thetibial component; a bone aperture formation reference slot extendingthrough at least a portion of the at least one bone aperture formationguide through hole; an anterior reference slot positioned in an anteriorend portion of the base portion corresponding to an anterior end of thetibial component; and a posterior reference slot positioned in aposterior end portion of the base portion corresponding to a posteriorend of the tibial component.
 13. The system according to claim 1,wherein the arm portion of the first component comprises a plurality ofpin through holes extending therethrough anteriorly-posteriorly.
 14. Thesystem according to claim 13, wherein the arm portion of the firstcomponent further comprises a medial wing and a lateral wing, the medialand lateral wings each comprising at least one pin through hole of theplurality of pin through holes, and wherein the at least one pin throughhole of the medial and lateral wings converge medially-laterally as theyextend posteriorly.
 15. The system according to claim 13, wherein theplurality of pin through holes comprise at least one pair of aligned pinthrough holes that are medially-laterally spaced.
 16. The systemaccording to claim 1, wherein the arm portion of the first componentcomprises a positioning mechanism that is configured to engage theanterior side of the resected distal tibia and adjust theanterior-posterior position of the base portion of the first componentrelative to the resected distal tibia, wherein the positioning mechanismcomprises at least one adjustment screw threadably coupled with the armportion.
 17. The system according to claim 1, wherein the first talarengagement surface is planar and is configured to engage a planarportion of the resected talus.
 18. The system according to claim 1,wherein the distal side of the second component further comprises amedially-laterally extending center reference slot extending through thefirst talar engagement surface corresponding to the medial-lateralcenter of the talar component, the medially-laterally extending centerreference slot being exposed at medial and lateral sides of the secondcomponent.
 19. The system according to claim 1, wherein the posteriorcut slot is exposed at medial and lateral sides of the second componentat the distal side of the second component.
 20. The system according toclaim 1, wherein the distal side of the second component furthercomprises a medially-laterally extending anterior reference slot, themedially-laterally extending anterior reference slot being exposed atmedial and lateral sides of the second component and corresponding tothe position and orientation of an anterior-posterior pathway of theposterior trial articulation surface at the distal side of the secondcomponent.
 21. The system according to claim 1, further comprising atleast one anterior cut guide configured to engage the proximal side ofthe second component and extend at least partially over the anteriorwindow, the at least one anterior cut guide comprising a bone cuttingguide through hole configured to mate with at least one cuttingimplement to form an anterior chamfer on the resected talus.
 22. Thesystem according to claim 21, wherein the distal side of the secondcomponent further comprises a medially-laterally extending anterior cutreference slot, the medially-laterally extending anterior cut referenceslot being exposed at medial and lateral sides of the second componentand corresponding to the position and orientation of the anteriorchamfer on the resected talus.
 23. The system according to claim 1,wherein the posterior cut slot is positioned anteriorly-posteriorlybetween at least a portion of the posterior trial articulation surfaceand the anterior window.
 24. The system according to claim 1, whereinthe posterior cut slot is configured to accept a cutting bladetherethrough to form a posterior chamfer on the resected talus.
 25. Thesystem according to claim 1, wherein the plurality of pin through holesof the second component comprise at least one pair of through holes thatare medially-laterally spaced and converge medially-laterally as theyextend from the proximal side to the distal side of the secondcomponent.
 26. The system according to claim 25, wherein the pluralityof pin through holes of the second component comprise at least one pairof aligned pin through holes that are medially-laterally spaced.
 27. Thesystem according to claim 1, wherein the system further comprises achamfer checker instrument, the chamfer checker instrument comprising atleast one fourth talar engagement surface configured to engage theresected talus, a fifth talar engagement surface extending from the atleast one fourth talar engagement surface configured to engage ananterior chamfer of the resected talus formed via the anterior window ofthe second component, and a sixth talar engagement surface extendingfrom the at least one fourth talar engagement surface configured toengage a posterior chamfer of the resected talus formed via the cut slotof the second component.
 28. The system according to claim 1, furthercomprising a bone aperture formation guide configured to couple to theanterior end portion of the talar chamfer trial, the bone apertureformation guide comprising a second elongated slot that extends over theelongated slot when coupled to the anterior end portion, the secondelongated slot configured to accept a bone cutting instrumenttherethrough to form an elongated aperture in the anterior chamfersurface of the resected talus formed via the anterior window of thesecond component.